Form 10-Q - Quarterly report [Sections 13 or 15(d)]

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the quarterly period ended September 30, 2024

☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the transition period from to

Commission File Number: 001-39752

Petros Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)


Delaware		85-1410058
(State of Incorporation)		(I. R. S. Employer Identification No.)

1185 Avenue of the Americas, 3rd Floor, New York, New York		10036
(Address of principal executive offices)		(Zip Code)

(973) 242-0005

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0001	PTPI	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 12, 2024, there were 10,014,872 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q may contain or incorporate by reference forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are based upon management’s assumptions, expectations, projections, intentions and beliefs about future events. Except for historical information, the use of predictive, future-tense or forward-looking words such as “intend,” “plan,” “predict,” “may,” “will,” “project,” “target,” “strategy,” “estimate,” “anticipate,” “believe,” “expect,” “continue,” “potential,” “forecast,” “should” and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify such forward-looking statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, including, without limitation, Petros’ ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros’ ability to comply with obligations as a public reporting company; Petros’ ability to regain and maintain compliance with the Nasdaq Stock Market’s listing standards; the ability of Petros to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; risks resulting from Petros’ status as an emerging growth company and smaller reporting company, including that reduced disclosure requirements may make shares of Petros common stock less attractive to investors; Petros’ ability to continue as a going concern; risks related to Petros’ history of incurring significant losses; risks related to Petros’ dependence on the commercialization of a single product, Stendra®; risks related to Petros’ ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are described in this Quarterly Report on Form 10-Q, in “Risk Factor Summary” and in Part I, Item 1A., “Risk Factors,” in Petros’ Annual Report on Form 10-K for the year ended December 31, 2023, as amended on May 31, 2024 (“2023 Form 10-K”) and in our other reports filed with the Securities and Exchange Commission (the “SEC”). We advise you to carefully review the reports and documents we file from time to time with the SEC, particularly our annual reports on Form 10-K, our quarterly reports on Form 10-Q and our current reports on Form 8-K. Petros cautions readers that the forward-looking statements included in, or incorporated by reference into, this Quarterly Report on Form 10-Q represent our beliefs, expectations, estimates and assumptions only as of the date hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, Petros cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement.

Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim any obligation to update the forward-looking statements contained in, or incorporated by reference into, this Quarterly Report on Form 10-Q to reflect any new information or future events or circumstances or otherwise, except as required by the federal securities laws.

OTHER INFORMATION

All references to “Petros,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Petros Pharmaceuticals, Inc. and its subsidiaries.

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TABLE OF CONTENTS

		Page

PART I—FINANCIAL INFORMATION		4

Item 1. Unaudited Financial Statements		4

Condensed Consolidated Balance Sheets as of September 30, 2024, and December 31, 2023		4

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024, and 2023		5

Condensed Consolidated Statements of Changes in Convertible Redeemable Preferred Stock and Stockholders’ Equity for the three and nine months ended September 30, 2024, and 2023		6

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024, and 2023		7

Notes to Condensed Consolidated Financial Statements		8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.		26

Item 3. Quantitative and Qualitative Disclosures About Market Risk.		41

Item 4. Controls and Procedures.		41

PART II—OTHER INFORMATION		43

Item 1. Legal Proceedings.		43

Item 1A. Risk Factors.		43

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.		44

Item 3. Defaults Upon Senior Securities.		44

Item 4. Mine Safety Disclosures.		44

Item 5. Other Information.		44

Item 6. Exhibits.		46

Signatures.		47

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PART I—FINANCIAL INFORMATION

ITEM 1. UNAUDITED FINANCIAL STATEMENTS.

PETROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	September 30,		December 31,
	2024		2023
	(Unaudited)
Assets
Current assets:
Cash	$	3,894,685	$	13,336,975
Accounts receivable, net		1,948,613		2,226,151
Inventories		1,405,651		1,610,391
Prepaid inventory		1,649,212		1,182,899
Prepaid expenses and other current assets		1,826,319		2,033,980
Total current assets		10,724,480		20,390,396

Fixed assets, net		18,819		28,957
Intangible assets, net		6,825,887		8,971,737
API purchase commitment		2,999,514		4,178,446
Right of use assets		124,930		226,259
Total assets	$	20,693,630	$	33,795,795

Liabilities, Convertible Redeemable Preferred Stock and Stockholders’ Equity
Current liabilities:
Current portion of promissory note	$	2,326,050	$	1,156,550
Accounts payable		1,600,992		1,713,253
Accrued expenses		6,539,371		5,360,077
Accrued Series A Convertible Preferred payments payable		1,742,918		2,047,583
Other current liabilities		352,773		493,288
Total current liabilities		12,562,104		10,770,751

Promissory note, net of current portion		4,922,585		6,857,364
Derivative Liability		—		3,550,000
Other long-term liabilities		91,832		137,657
Total liabilities		17,576,521		21,315,772

Commitments and contingencies (see note 14)
Series A convertible redeemable preferred stock (par value $0.0001 per share and $1,000 stated value), 15,000 and 15,000 shares authorized at September 30, 2024, and December 31, 2023, respectively; 1,039 and 10,022 shares issued and outstanding at September 30, 2024, and December 31, 2023, respectively; Liquidation preference of $1,260,385 and $11,271,365, as of September 30, 2024, and December 31, 2023, respectively.		1,398		408,982

Stockholders’ Equity:
Common stock (par value $0.0001 per share, 250,000,000 and 250,000,000 shares authorized at September 30, 2024, and December 31, 2023, respectively; 10,014,872 and 2,991,377 shares issued and outstanding as of September 30, 2024, and December 31, 2023, respectively)		1,002		298
Additional paid-in capital		107,049,640		110,960,324
Accumulated deficit		(103,934,931)		(98,889,581)
Total Stockholders’ Equity		3,115,711		12,071,041

Total Liabilities, Convertible Redeemable Preferred Stock and Stockholders’ Equity	$	20,693,630	$	33,795,795

The accompanying Notes are an integral part of the Unaudited Condensed Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)


	For the Nine Months Ended September 30,				For the Three Months Ended September 30,
	2024		2023		2024		2023
Net sales	$	4,386,640	$	6,186,638	$	1,576,366	$	1,674,657
Cost of goods sold		947,946		1,473,073		287,005		408,475
Gross profit		3,438,694		4,713,565		1,289,361		1,266,182
Operating expenses:
Selling, general and administrative		7,299,391		6,382,166		2,301,305		2,001,935
Warrant issuance costs		—		2,855,000		—		2,855,000
Research and development expense		2,513,105		1,574,760		588,355		389,093
Depreciation and amortization expense		2,175,126		2,480,385		739,449		826,795
Total operating expenses		11,987,622		13,292,311		3,629,109		6,072,823

Loss from operations		(8,548,928)		(8,578,746)		(2,339,748)		(4,806,641)
Other income (expenses):
Change in fair value of derivative liability		3,550,000		(430,000)		202,000		(430,000)
Change in fair value of warrant liability		—		11,739,000		—		11,739,000
Interest income		347,028		287,722		75,817		168,481
Interest expense, promissory note		(393,450)		(410,317)		(158,730)		(131,351)
Loss on issuance of Series A Preferred Stock		—		(11,088,997)		—		(11,088,997)
Total other income		3,503,578		97,408		119,087		257,133
Net loss before income taxes	$	(5,045,350)	$	(8,481,338)	$	(2,220,661)	$	(4,549,508)
Provision for income taxes		—		—		—		—
Net loss	$	(5,045,350)	$	(8,481,338)	$	(2,220,661)	$	(4,549,508)

Preferred Stock dividend and cash premiums		(1,863,998)		(339,232)		(1,051,695)		(339,232)
Preferred Stock accretion		(9,099,230)		(1,153,846)		(1,974,359)		(1,153,846)

Net loss attributable to common stockholders		(16,008,578)		(9,974,416)		(5,246,715)		(6,042,586)
Basic and Diluted	$	(2.18)	$	(4.73)	$	(0.53)	$	(2.85)
Weighted average common shares outstanding
Basic and Diluted		7,332,030		2,108,747		9,829,793		2,119,620

The accompanying Notes are an integral part of the Unaudited Condensed Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(Unaudited)


		Convertible
	Convertible	Redeemable
	Redeemable	Preferred			Common		Additional
	Preferred	Stock		Common	Stock		Paid-in		Accumulated
	Stock	Amount		Stock	Amount		Capital		Deficit		Total
Three Months Ended September 30, 2024
Balance, June 30, 2024	4,039	$	1,115,762	9,297,538	$	930	$	109,783,623	$	(101,714,270)	$	8,070,283
Stock-based compensation expense	—		—	—		—		—		—		—
Common Stock issued for services	—		—	136,986		14		59,986		—		60,000
Series A Preferred Stock accretion	—		1,974,359	—		—		(1,974,359)		—		(1,974,359)
Series A Preferred Stock dividends	—		236,821	—		—		(236,821)		—		(236,821)
Preferred Stock redemption including cash premium	(3,000)		(3,325,544)	580,348		58		232,085		—		232,143
Deemed dividends on Preferred Stock	—		—	—		—		(814,874)		—		(814,874)
Net loss	—		—	—		—		—		(2,220,661)		(2,220,661)
Balance, September 30, 2024	1,039	$	1,398	10,014,872	$	1,002	$	107,049,640	$	(103,934,931)	$	3,115,711


		Convertible
	Convertible	Redeemable
	Redeemable	Preferred			Common		Additional
	Preferred	Stock		Common	Stock		Paid-in		Accumulated
	Stock	Amount		Stock	Amount		Capital		Deficit		Total
Nine Months Ended September 30, 2024
Balance, December 31, 2023	10,022	$	408,982	2,991,377	$	298	$	110,960,324	$	(98,889,581)	$	12,071,041
Stock-based compensation expense	—		—	—		—		197,215		—		197,215
Common Stock issued for services	—		—	459,972		47		269,953		—		270,000
Series A Preferred Stock accretion	—		9,099,230	—		—		(9,099,230)		—		(9,099,230)
Series A Preferred Stock dividends	—		991,783	—		—		(991,783)		—		(991,783)
Preferred Stock redemption including cash premium	(8,983)		(10,498,597)	6,563,523		657		6,585,376		—		6,586,033
Deemed dividends on Preferred Stock	—		—	—		—		(872,215)		—		(872,215)
Net loss	—		—	—		—		—		(5,045,350)		(5,045,350)
Balance, September 30, 2024	1,039	$	1,398	10,014,872	$	1,002	$	107,049,640	$	(103,934,931)	$	3,115,711


		Convertible
	Convertible	Redeemable
	Redeemable	Preferred			Common		Additional
	Preferred	Stock		Common	Stock		Paid-in		Accumulated
	Stock	Amount		Stock	Amount		Capital		Deficit		Total
Three Months Ended September 30, 2023
Balance, June 30, 2023	—	$	—	2,119,620	$	211	$	107,602,301	$	(94,658,223)	$	12,944,289
Stock-based compensation expense	—		—	—		—		30,840		—		30,840
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003	15,000		—	—		—		—		—		—

Series A Preferred Stock accretion	—		1,153,846	—		—		(1,153,846)		—		(1,153,846)
Series A Preferred Stock dividends	—		249,701	—		—		(249,701)		—		(249,701)
Preferred Stock redemption including cash premium	(1,154)		(1,279,016)	—		—		(89,531)		—		(89,531)
Net loss	—		—	—		—		—		(4,549,508)		(4,549,508)
Balance, September 30, 2023	13,846	$	124,531	2,119,620	$	211	$	106,140,063	$	(99,207,731)	$	6,932,543


		Convertible
	Convertible	Redeemable
	Redeemable	Preferred			Common		Additional
	Preferred	Stock		Common	Stock		Paid-in		Accumulated
	Stock	Amount		Stock	Amount		Capital		Deficit		Total
Nine Months Ended September 30, 2023
Balance, December 31, 2022	—	$	—	2,079,387	$	208	$	107,428,652	$	(90,726,393)	$	16,702,467
Stock-based compensation expense	—		—	—		—		204,492		—		204,492
Shares issued for vested RSU’s	—		—	40,233		3		(3)		—		—
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003	15,000		—	—		—		—		—		—

Series A Preferred Stock accretion	—		1,153,846	—		—		(1,153,846)		—		(1,153,846)
Series A Preferred Stock dividends	—		249,701	—		—		(249,701)		—		(249,701)
Preferred Stock redemption including cash premium	(1,154)		(1,279,016)	—		—		(89,531)		—		(89,531)
Net loss	—		—	—		—		—		(8,481,338)		(8,481,338)
Balance, September 30, 2023	13,846	$	124,531	2,119,620	$	211	$	106,140,063	$	(99,207,731)	$	6,932,543

The accompanying Notes are an integral part of the Unaudited Condensed Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)


	For the Nine Months Ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(5,045,350)	$	(8,481,338)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		2,175,126		2,480,385
Bad debt expense		16,579		32,516
Inventory and sample inventory reserve		(35,055)		41,195
Amortization of right of use asset		101,328		97,622
Derivative liability		(3,550,000)		430,000
Warrant liability		—		(11,739,000)
Loss on issuance of Series A Preferred Stock		—		11,088,997
Noncash Warrant expense		—		1,595,000
Employee stock-based compensation		197,215		204,492
Stock issued for services		270,000		—

Changes in operating assets and liabilities:
Accounts receivable		260,959		(897,289)
Inventories		239,795		(63,191)
Prepaid inventory		(466,313)		—
Prepaid expenses and other current assets		1,386,593		359,492
Accounts payable		(112,287)		(451,338)
Accrued expenses		1,179,294		234,364
Deferred revenue		(46,895)		(281,372)
Other current liabilities		(93,620)		94,113
Other long-term liabilities		(45,825)		(111,283)
Net cash used in operating activities		(3,568,456)		(5,366,635)

Cash flows from investing activities:
Acquisition of fixed assets		(19,138)		—
Net cash used in investing activities		(19,138)		—

Cash flows from financing activities:
Payment of promissory note		(765,279)		(1,089,683)
Proceeds from Private Placement, net of transactions costs		—		15,000,003
Redemption of Series A Preferred Stock		(5,089,417)		—
Net cash provided by (used in) financing activities		(5,854,696)		13,910,320

Net increase (decrease) in cash		(9,442,290)		8,543,685

Cash, beginning of period		13,336,975		9,426,264
Cash, end of period	$	3,894,685	$	17,969,949

Supplemental cash flow information:
Cash paid for interest during the period	$	234,721	$	410,317

Noncash Items:
Noncash increase in inventory due to API reclass	$	—	$	(663,984)
Noncash decrease in API purchase commitment		—		694,314
Noncash decrease in other current assets: API purchase commitment		—		(30,330)
Noncash issuance of common stock to non-employee		—		3
Noncash initial fair value of warrant liability pursuant to private placement		—		21,544,000
Noncash initial fair value of derivative liability pursuant to private placement		—		6,140,000
Noncash redemption of Series A Preferred Stock		6,586,033		—
Accrued Series A Convertible Preferred payments payable		1,742,918		1,368,546
Accretion of Series A convertible preferred stock to redemption value		9,099,230		1,153,846
Accrual of Series convertible preferred stock dividends		991,783		339,232

The accompanying Notes are an integral part of the Unaudited Condensed Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1) Nature of Operations, Basis of Presentation, Liquidity and Going Concern

Nature of Operations

Petros Pharmaceuticals, Inc. (“Petros” or the “Company”) was incorporated in Delaware on May 14, 2020, for the purpose of effecting the transactions contemplated by that certain Agreement and Plan of Merger, dated as of May 17, 2020 (as amended, the “Merger Agreement”), by and between Petros, Neurotrope, Inc., a Nevada corporation (“Neurotrope”), Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”), and certain subsidiaries of Petros and Neurotrope. Petros consists of wholly owned subsidiaries: Metuchen, Neurotrope, Timm Medical Technologies, Inc. (“Timm Medical”), and Pos-T-Vac, LLC (“PTV”). The Company is engaged in the commercialization and development of Stendra®, a U.S. Food and Drug Administration (“FDA”) approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction (“ED”), which the Company has licensed from Vivus, Inc. (“Vivus”). Petros also markets its own line of ED products in the form of vacuum erection device products through its subsidiaries, Timm Medical and PTV.

Petros is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-The-Counter (“OTC”) treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, Stendra®, via potential OTC designation. If ultimately approved by the FDA for OTC access, Stendra® may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics.

The Company manages its operations through two segments, Prescription Medications and Medical Devices, both of which focus on the treatment of ED. The Prescription Medications segment consists primarily of Stendra®, which is sold generally in the United States. The Medical Devices segment consists primarily of vacuum erection devices, which are sold domestically and internationally.

The Company’s priority is the ability to develop Stendra® OTC and its commercialization.

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. In the opinion of management, the unaudited condensed consolidated financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the nine months ended September 30, 2024, may not be indicative of results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2023, included in the Company’s 2023 Form 10-K. All transactions between the consolidated entities have been eliminated in consolidation.

Liquidity, Going Concern and Other Uncertainties

In accordance with Financial Accounting Standards Board (the “FASB”) Accounting Standards Update (“ASU”) ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. To date, the Company’s principal sources of capital used to fund operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities. The Company has experienced net losses and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash of $3.9 million, negative working capital of $1.8 million, and accumulated deficit of $103.9 million. The Company’s plans include, or may include, utilizing cash on hand, as well as exploring additional ways to raise capital in addition to increasing cash flows from operations.

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In January 2022, the Company executed a promissory note in favor of Vivus in connection with the Vivus Settlement Agreement (as defined herein) in the principal amount of $10,201,758 (the “Settlement Agreement”). As of September 30, 2024, the principal balance of the note is $7.2 million. The terms of this promissory note are discussed in Note 8 and Note 13.

The Company does not currently have sufficient available liquidity to fund its operations for at least the next 12 months. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these interim unaudited condensed consolidated financial statements are issued. The accompanying interim unaudited condensed consolidated financial statements do not include any adjustments that might result from these uncertainties. The unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

In response to these conditions and events, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating, debt service and capital requirements for the next twelve months following the date of this Quarterly Report. The potential sources of financing that the Company is evaluating include one or any combination of secured or unsecured debt, convertible debt and equity in both public and private offerings. The Company also plans to finance near-term operations with its cash on hand, including the gross proceeds of $15 million raised in the Private Placement (as defined herein), as well as by exploring additional ways to raise capital and increasing cash flows from operations. The Company intends to use the proceeds from the Private Placement to fund its OTC progress throughout 2024. There is no assurance the Company will manage to raise additional capital or otherwise increase cash flows, if required. The sources of financing described above that could be available to the Company and the timing and probability of obtaining sufficient capital depend, in part, on expanding the use of Stendra® and continuing to invest in research and development pursuant to the Company’s Non-Prescription / OTC strategies related to Stendra®, which the Company believes has the potential to dramatically increase product sales in the future and future capital market conditions. If the Company’s current assumptions regarding timing of these events are incorrect or if there are any other changes or differences in the Company’s current assumptions that negatively impact the Company’s financing strategy, the Company may have to further reduce expenditures or significantly delay, scale back or discontinue the development or commercialization of Stendra® OTC in order to extend its cash resources.

NASDAQ Capital Market Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard

On May 15, 2024, the Company received notice from the Listing Qualifications Staff of Nasdaq (the “Staff”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between April 3, 2024, through May 14, 2024, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). The letter also indicated that the Company was provided with a compliance period until November 11, 2024, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

On November 12, 2024, the Company received notice from the Staff granting the Company’s request for a 180-day extension to regain compliance with the Rule, or, until May 12, 2025 (the “Compliance Period”).In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency Nasdaq will provide notice that the Company’s common stock will be subject to delisting. There can be no assurance that the Nasdaq staff would grant the Company’s request for continued listing subsequent to any delisting notification. In the event of such a notification, the Company may appeal the Nasdaq staff’s determination to delist its securities.

2) Summary of Significant Accounting Policies

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenue and expenses during the reporting periods. Such estimates include the adequacy of accounts receivable reserves, return reserves, inventory reserves, assessment of long-lived assets, including intangible asset impairment, and the valuation of the derivative liability, among others. Actual results could differ from these estimates and changes in these estimates are recorded when known.

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Risks and Uncertainties

The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of competitor products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, and protection of intellectual property rights.

Concentration of Credit Risk

Financial instruments that subject the Company to concentrations of credit risk includes cash. The Company maintains cash on deposit at U.S.-based banks in amounts which, at times, may be in excess of insured limits of $250,000.

Segment Reporting

Operating segments are components of a Company for which separate financial information is available and evaluated regularly by the chief operating decision maker in assessing performance and deciding how to allocate resources. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of ED. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States. The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. See Note 15 Segment Information.

Revenue Recognition

Prescription Medication Sales

The Company’s prescription medication sales consist of sales of Stendra® in the U.S. for the treatment of ED. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue Recognition (“Topic 606”), the Company recognizes revenue from prescription medication sales when its performance obligations with a customer have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide Stendra® upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of Stendra®, which is typically upon delivery. The Company invoices its customers after Stendra® has been delivered and invoice payments are generally due within 30 to 75 days of invoice date.

In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers Stendra® to when the customers pay for the product is typically less than one year. The Company records prescription medication sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and distribution service fees (“DSA”). The Company uses the expected value method when estimating its variable consideration, unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales of Stendra® are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.

As of September 30, 2024, and December 31, 2023, the reserves for sales deductions were $5.5 million and $4.7 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and DSA fees. The Company’s estimates are based on factors such as direct and indirect customers’ buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with the Company’s direct and indirect customers, and other competitive factors. Significant judgment and estimation are required in developing the foregoing and other relevant assumptions. The most significant sales deductions are further described below.

Product Returns

Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return Stendra® and receive credit for product within six months prior to expiration date and up to one year after expiration date. The provision for returns is based upon the Company’s estimates for future Stendra® returns and historical experience. The provision of returns is part of the variable consideration recorded at the time revenue is recognized. As of September 30, 2024, and December 31, 2023, the reserves for product returns were $5.3 million and $4.2 million, respectively, and are included as a component of accrued expenses. During the nine months ended September 30, 2024, and 2023, the Company recorded $1.2 million and $1.3 million, respectively, of returns as a reduction of gross revenue. During the three months ended September 30, 2024, and 2023, the Company recorded $0.4 million and $0.5 million, respectively, of returns as a reduction of gross revenue.

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Contract Rebates, Coupon Redemptions and DSA Fees

The Company establishes contracts with wholesalers, chain stores, and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under the Company’s DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with us.

The Company has entered into DSAs with certain significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for the Company’s pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves.

Medical Device Sales

The Company’s medical device sales consist of domestic and international sales of men’s health products for the treatment of ED. The men’s health products do not require a prescription and include vacuum erection devices, PreBoost, VenoSeal, penile injections (Rx), and urinary tract infection tests. Under Topic 606, the Company recognizes revenue from medical device sales when its performance obligations with its customers have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide medical devices upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the medical device, which is typically upon shipment. The Company invoices its customers after the medical devices have been shipped and invoice payments are generally due within 30 days of invoice date for domestic customers and 90 days for international customers.

In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers the medical devices to when the customers pay for the product is typically less than one year. The Company records medical device sales net of any variable consideration, including but not limited to returns. The Company uses the expected value method when estimating its variable consideration. The identified variable consideration is recorded as a reduction of revenue at the time revenues from the medical device sales are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.

Product Returns

Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return medical devices and receive credit for products within 90 days of the sale. The provision for returns is based upon the Company’s estimates for future product returns and historical experience. The Company has not made significant changes to the judgments made in applying Topic 606. As of September 30, 2024, and December 31, 2023, the reserves for product returns for medical devices were not significant.

Contract Costs

In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred. As such, the Company did not have any contract assets at September 30, 2024, and December 31, 2023.

Contract Liabilities

Under Accounting Standards Codification Topic 606, Revenue Recognition, the Company recognizes revenue when its performance obligations with a customer has been satisfied. In the event it has not been satisfied, the Company records deferred revenue as a liability on the balance sheet. As of September 30, 2024, and December 31, 2023, deferred revenue was $0.1 million and $0.1 million, respectively.

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Fair Value of Financial Instruments

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy:

Level 1 – Quoted prices in active markets for identical assets or liabilities.

Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market.

Level 3 – Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Financial instruments recognized at historical amounts in the consolidated balance sheets consist of cash, accounts receivable, other current assets, accounts payable, accrued expenses, and other current liabilities. The Company believes that the carrying values of cash, accounts receivable, other current assets, accounts payable, accrued expenses, note payable, and other current liabilities approximate their fair values due to the short-term nature of these instruments.

In connection with the Private Placement (as defined herein), the Company incurred liabilities related to derivatives arising from embedded features that were not clearly and closely related to the host instruments. The Company estimated the fair value of derivative liability utilizing Monte Carlo Simulation approach. These fair value measurements are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. See Notes 16 and 17.

Intangible Assets

The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life that the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are amortized using an accelerated method based on the pattern in which the economic benefits of the assets are consumed. The Company reviews the carrying value and useful lives of its intangible assets with definite lives whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or the period over which they should be amortized has changed. When indicators of impairment exist, the Company determines whether the estimated undiscounted sum of the future cash flows of such assets is less than their carrying amounts. If less, an impairment loss is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values. The Company evaluates the remaining useful life of each intangible asset that is being amortized during each reporting period to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life.

The Company’s prepared projections including the undiscounted cash flows of the remaining estimated useful lives through December 2031 for the medical device products. Management continued to analyze the Company’s intangible assets during 2024. Management noted that the Company’s financial results were consistent with previous projections. Based on its analysis, Management concluded that there were no triggering events noted that would indicate a potential impairment for long-lived assets for any of the two asset groups, Metuchen Pharmaceuticals and TIMM/PTV.

Derivative Financial Instruments

The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging (“ASC 815”). Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations each period. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet.

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Preferred Stock

The Company records shares of convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company concluded that the Series A Preferred Stock is more akin to a debt-type instrument than an equity-type instrument, therefore certain conversion features associated with the convertible preferred stock were deemed to not be clearly and closely related to the host instrument and were bifurcated as a derivative under ASC 815. The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities and has therefore classified the Series A convertible preferred stock as mezzanine equity as it redeemable in monthly installments. The Company adjusts the carrying values of the convertible preferred stock by accreting the discount and accruing dividends to the state the convertible preferred stock at redemption value each reporting period.

Recent Accounting Pronouncements

Accounting Pronouncements Not Yet Adopted

In November 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance will be effective for the annual periods beginning the year ended December 31, 2024, and for interim periods beginning January 1, 2025. Early adoption is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating segment disclosures related to its annual report for fiscal year 2024.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company is currently evaluating income tax disclosures related to its annual report for fiscal year 2025.

In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures.

3) Accounts Receivable, net

Accounts receivable, net is comprised of the following:


	September 30,		December 31,
	2024		2023
Gross accounts receivables	$	2,299,300	$	2,887,317
Distribution service fees		(114,073)		(398,968)
Chargebacks accrual		(2,946)		(2,462)
Cash discount allowances		(26,066)		(24,639)
Allowance for credit losses		(207,602)		(235,097)
Total accounts receivable, net	$	1,948,613	$	2,226,151

For the nine months ended September 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 28%, 25%, and 14% of total gross billings, respectively. For the nine months ended September 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 23%, 19%, and 17% of total gross billings, respectively. For the three months ended

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September 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 30%, 25%, and 14% of total gross billings, respectively. For the three months ended September 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 24%, 21%, and 18% of total gross billings, respectively.

Receivables from customers representing 10% or more of the Company’s gross accounts receivable included three customers at September 30, 2024, equal to 53%, 25%, and 22%, respectively. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included three customers at December 31, 2023, equal to 36%, 24% and 16%, respectively.

Effective November 1, 2024, the Company determined to discontinue sales of Stendra® to wholesalers to mitigate the risk of returns associated with expired or near-expired prescription medication due to Stendra® having less than a six-month shelf life. Sales of Stendra® to wholesalers collectively accounted for approximately 94% and 95% of net sales for the three months ended and nine months ended September 30, 2024, respectively.

4) Inventories

Inventory is comprised of the following:


	September 30, 2024		December 31, 2023
Raw Materials	$	1,257,152	$	1,430,139
Finished goods		148,499		180,252
Total inventory	$	1,405,651	$	1,610,391

Finished goods are net of valuation reserves of $260,356 and $295,411 as of September 30, 2024, and December 31, 2023, respectively.

5) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets are comprised of the following:


	September 30, 2024		December 31, 2023
Prepaid insurance	$	94,030	$	45,664
Prepaid FDA fees		—		937,652
Prepaid R&D expenses		208,900		115,755
API purchase commitment asset (see Note 13)		1,417,348		704,729
Other prepaid expenses		101,281		118,704
Other current assets		4,760		111,476
Total prepaid expenses and other current assets	$	1,826,319	$	2,033,980

6) Intangible Assets

Intangible Assets are comprised of the following:


Balance at December 31, 2022	$	12,244,484
Amortization expense		(3,272,747)
Balance at December 31, 2023		8,971,737
Amortization expense		(2,145,850)
Balance at September 30, 2024	$	6,825,887

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The future annual amortization related to the Company’s intangible assets is as follows as of September 30, 2024:


2024 (remaining 3 months)	$	654,774
2025		1,754,329
2026		1,442,186
2027		1,212,871
2028		996,636
Thereafter		765,091
Total	$	6,825,887

The intangible assets held by the Company are the Stendra® product, Timm Medical product, and PTV product and are being amortized over their estimated useful lives of 10 years, 12 years, and 12 years, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of September 30, 2024, are $3.4 million, $2.7 million and $0.7 million, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of December 31, 2023, were $4.9 million, $3.2 million and $0.9 million, respectively. During the nine months ended September 30, 2024, and 2023, respectively, the Company recorded $2.1 million and $2.5 million of amortization expense. During the three months ended September 30, 2024, and 2023, respectively, the Company recorded $0.7 million and $0.8 million of amortization expense.

7) Accrued Expenses

Accrued expenses are comprised of the following:


	September 30, 2024		December 31, 2023
Accrued product returns	$	5,299,261	$	4,178,176
Accrued contract rebates		96,465		128,562
Due to 3PL/Wholesalers		62,284		75,727
Accrued bonuses		501,988		665,184
Accrued professional fees		—		15,000
Accrued R&D fees		354,908		100,668
Other accrued expenses		224,465		196,760
Total accrued expenses	$	6,539,371	$	5,360,077

8) Debt

Promissory Note

In connection with the Settlement Agreement entered into with Vivus (see Note 13), Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the principal amount of $10,201,758. The parties also entered into a Security Agreement, dated January 18, 2022, (the “Security Agreement”) pursuant to which the Company granted to Vivus a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement to secure the Company’s obligations under the Note (the “Collateral”).

Under the terms of the Note, the original principal amount of $10,201,758 is payable in consecutive quarterly installments of principal and interest beginning on April 1, 2022, through January 1, 2027. Interest on the principal amount accrues at a rate of 6% per year. The Company may prepay the Note, in whole or in part, at any time, with no premium or penalty. In the event of a default under the Security Agreement, all principal outstanding under the Note at the time of the default will bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note (regardless of whether any default is waived or cured). For the nine months ended September 30, 2024, and 2023, the Company paid Vivus $1.0 million and $1.5 million, respectively. As of September 30, 2024, and December 31, 2023, the principal balance on the Note is $7.2 million and $8.0 million, respectively.

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Future minimum principal payments of the Note are as follows:


2024 (remaining 3 months)	$	391,271
2025		2,720,940
2026		3,264,351
2027		872,073
Total	$	7,248,635
Less: current portion		(2,326,050)
Promissory note, net of current portion	$	4,922,585

9) Stockholders’ Equity

On December 21, 2023, the Company approved and accrued for the issuance of $200,000 of common stock, payable in two equal installments, with the first installment to be paid upon approval by the Board and the second installment six months after the first installment, to CorProminence, LLC (“CoreIR”) for services rendered pursuant to a Marketing and Consulting Agreement. The first installment of 70,922 shares was issued on February 29, 2024. The second installment of 245,158 shares was issued on June 21, 2024.

On January 5, 2024, the Company executed an advisory agreement (“Maxim Agreement”) with Maxim Group LLC (“Maxim”) that included the issuance of $10,000 of the Company’s restricted common stock per month and issued every six months starting upon the execution of the agreement. The first installment of 6,906 shares was issued on January 5, 2024. The second installment of 136,986 shares was issued on August 13, 2024. On August 20, 2024, the Company delivered written notice of termination of the Maxim Agreement, effective September 30, 2024. Accordingly, the Maxim Agreement terminated in accordance with its terms on September 30, 2024.

10) Stock Options

The following is a summary of stock options for the nine months ended September 30, 2024:


				Weighted-Average
		Weighted-		Remaining	Aggregate Intrinsic
	Number of	Average		Contractual	Value
	Shares	Exercise Price		Term (Years)	($ in thousands)
Options outstanding at December 31, 2023	509,133	$	4.75	9.46	$	66
Options granted	—		—	—		—
Less: options forfeited	—		—	—		—
Less: options expired/cancelled	—		—	—		—
Less: options exercised	—		—	—		—
Options outstanding at September 30, 2024	509,133	$	4.75	8.71	$	—
Options exercisable at September 30, 2024	454,600	$	5.15	8.65	$	—

Stock-based compensation expense recognized for the nine months ended September 30, 2024, and 2023 was $197,215 and $204,492, respectively, and is recorded in general and administrative expenses in the consolidated statements of operations. As of September 30, 2024, there is no unrecognized stock-based compensation expense (excluding performance awards). Stock-based compensation expense recognized for the three months ended September 30, 2024, and 2023 was $0 and $30,840, respectively.

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11) Common Stock Warrants

The following is a summary of warrants for the nine months ended September 30, 2024:


					Aggregate
					Intrinsic
		Weighted-Average		Remaining	Value ($ in
	Number of Warrants	Exercise Price		Contractual Term	thousands)
Warrants outstanding - December 31, 2023	8,203,839	$	14.93	4.3	$	—
Warrants issued	—		—	—		—
Warrants exercised	—		—	—		—
Warrants expired	(15,097)		252.53	—		—
Warrants outstanding and exercisable- September 30, 2024	8,188,742	$	14.49	3.5	$	—

12) Dilutive convertible securities

The following table summarizes the potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net income (loss) per share because their inclusion would have been antidilutive:


	For the Three Months Ended		For the Nine Months Ended
	September 30,		September 30,
	2024	2023	2024	2023
Stock Options	509,133	210,067	509,133	210,067
Series A Convertible Preferred stock	560,171	6,762,090	560,171	6,762,090
Warrants	8,188,742	8,204,117	8,188,742	8,204,117
Total	9,258,046	15,176,274	9,258,046	15,176,274

13) Marketing, Licensing and Distribution Agreements

(a) Vivus

On September 30, 2016, the Company entered into a License and Commercialization Agreement (the “License Agreement”) with Vivus to purchase and receive the license for the commercialization and exploitation of Stendra® for a one-time fee of $70 million. The License Agreement gives the Company the right to sell Stendra® in the U.S and its territories, Canada, South America, and India. Vivus was originally granted the license in December 2000 from Mitsubishi Tanabe Pharma Corporation (“MTPC”) to develop, market, and manufacture Stendra®. Stendra® was approved by the FDA in April 2012 to treat ED.

Under the License Agreement, the Company will pay MTPC a royalty of 5% on the first $500 million of net sales and 6% of net sales thereafter. In consideration for the trademark assignment and the use of the trademarks associated with the product and the Vivus technology, the Company shall (a) during the first, second, and third years following the expiration of the Royalty Period in a particular country in the Company’s territory, pay to Vivus a royalty equal to 2% of the net sales of products in such territory; and (b) following the fourth and fifth years following the expiration of the Royalty Period in such territory, pay to Vivus a royalty equal to 1% of the net sales of products in such territory. Thereafter, no further royalties shall be owed with respect to net sales of Stendra® in such territory.

In addition, the Company will be responsible for a pro-rata portion of a $6 million milestone payment to be paid once $250 million in sales has been reached on the separate revenue stream of Stendra®. Should the $250 million of sales threshold be reached, the Company will be responsible for $3.2 million of the milestone payment.

On January 18, 2022, Petros and Vivus entered into a Settlement Agreement (the “Vivus Settlement Agreement”) related to the minimum purchase requirements under the Vivus Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company’s Stendra® product that were delivered to the third-party retailer and later returned. In connection with the Vivus Settlement Agreement, Petros retained approximately $7.3 million of Active Pharmaceutical Ingredient (“API”) inventory under the Vivus Supply Agreement. In exchange for the API and reduction of current liabilities after prepayment of $900,000, Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the original principal amount of $10,201,758, which the Company believes approximates fair value (See Note 8).

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As a result of entering into the Vivus Settlement Agreement, the Company decreased accrued expenses by $6.5 million and decreased accrued inventory purchases by $14.2 million; which were partially offset by a decrease in API purchase commitments of $6.2 million and an increase to liabilities for the Note of $10.2 million (which is net of the $0.9 million prepayment on the Note). As a result, the Company recorded a $3.4 million gain on settlement for the year ended December 31, 2022.

API inventory is not a finished good. The additional API inventory that the Company does not have title to is classified as API Inventory in either other current assets or other assets, depending on whether the Company expects to take title to the product within one year from the date of the financial statements. As of September 30, 2024, and December 31, 2023, there was $1.4 million and $0.7 million respectively, included in other current assets (see Note 5 Prepaid Expenses and Other Current Assets). As of September 30, 2024, and December 31, 2023, there was $3.0 million and $4.2 million, respectively,included as other assets on the accompanying consolidated balance sheets, respectively. The Company reviews its inventory levels and purchase commitments for excess amounts that it is required to purchase but projects it will not be able to sell prior to product expiry. The Company did not record any reserve for the three and nine months ended September 30, 2024, and 2023.

During the nine months ended September 30, 2024, and 2023, the Company incurred royalties to MTPC for Stendra® of $104,309 and $170,822, respectively. During the three months ended September 30, 2024, and 2023, the Company incurred royalties to MTPC for Stendra® of $42,903 and $46,288, respectively. Royalties incurred were included in cost of goods sold in the consolidated statements of operations. As of September 30, 2024, the Company had a payable for royalties of $42,903, which is included in accrued expenses in the accompanying consolidated balance sheets. As of December 31, 2023, the Company had a receivable for royalties of $56,503, which is included in other current assets. (see Note 7 Accrued Expenses and Note 5 Prepaid Expenses and other Current Assets).

The license agreement between MTPC and Vivus (“MTPC License”) contains certain termination rights that would allow MTPC to terminate the agreement if Vivus were to breach any of the terms of the MTPC License or become insolvent or bankrupt. In the event that MTPC terminates the MTPC License with Vivus because of any contractual breach the Company has step-in rights with MTPC, which would allow the Company to continue to sell Stendra®.

(b) Patheon

Following the termination of the Vivus Supply Agreement, Petros, through its subsidiary Metuchen, entered into a Technology Transfer Service Agreement on January 20, 2022, with Patheon Pharmaceuticals Inc., part of Thermo Fisher Scientific (“Patheon”), pursuant to which the Company and Patheon agreed to collaborate as strategic partners for commercial production of Stendra® tablets at Patheon’s facilities in Cincinnati, Ohio. Under the agreement, Patheon or one of its affiliates will provide pharmaceutical development and technology transfer services in order to establish and validate its ability to manufacture supply of the Company’s Stendra® product. Any commercial sale of product manufactured during the performance of the agreement must be subject to a subsequent commercial manufacturing services agreement (with associated quality agreement) between the parties before it can be offered for commercial sale.

14) Commitments and Contingencies

(a) Legal Proceedings

On July 14, 2020, Greg Ford, the former Chief Executive Officer of the Company, was terminated. On July 14, 2020, Mr. Ford, through his attorney, claimed that he was entitled to severance pay pursuant to an employment agreement following the termination of his employment on that same date. This claim is currently at an early stage where the Company is unable to determine the likelihood of any unfavorable outcome.

From time to time, the Company is involved in various legal matters arising in the normal course of business. The Company does not expect the outcome of such proceedings, either individually or in the aggregate, to have a material effect on the Company’s financial position, cash flows or results of operations.

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(b) Contract Research

The Company is currently conducting non-clinical consumer studies in connection with the pursuit of potential FDA approval for Stendra® Non-Prescription OTC use in treating ED. The Company has contracted with a leading Contract Research Organization (“CRO”) in the conduct of Rx-to-OTC Switch development including self-selection studies, human factors studies and various web app studies. The Company has committed approximately $1.8 million through multiple task orders/statements of work with the CRO to perform these studies. As of September 30, 2024, these projects are approximately 91% complete. The Company expects the CRO to complete these studies during the fourth quarter of 2024.

15) Segment Information

The Company manages its operations through two segments. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of ED. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States. The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. The Company separately presents the costs associated with certain corporate functions as Corporate, primarily consisting of unallocated operating expenses including costs that were not specific to a particular segment but are general to the group, expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees and other similar corporate expenses. Interest and other income (expense), net is also not allocated to the operating segments.

The Company’s results of operations by reportable segment for the nine months ended September 30, 2024, are summarized as follows:


	Prescription		Medical
For the Nine Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	2,086,180	$	2,300,460	$	—	$	4,386,640
Cost of goods sold		194,035		753,911		—		947,946
Selling, general and administrative expenses		1,774,594		1,673,122		3,851,675		7,299,391
Research and development expenses		2,513,105		—		—		2,513,105
Depreciation and amortization expense		1,522,207		652,919		—		2,175,126
Change in fair value of derivative liability		—		—		(3,550,000)		(3,550,000)
Interest income		—		—		(347,028)		(347,028)
Interest expense		—		—		393,450		393,450
Net loss	$	(3,917,761)	$	(779,492)	$	(348,097)	$	(5,045,350)

The Company’s results of operations by reportable segment for the nine months ended September 30, 2023, are summarized as follows:


	Prescription		Medical
For the Nine Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	3,416,444	$	2,770,194	$	—	$	6,186,638
Cost of goods sold		343,109		1,129,964		—		1,473,073
Selling, general and administrative expenses		1,006,666		1,398,890		3,976,610		6,382,166
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		1,499,842		74,918		—		1,574,760
Depreciation and amortization expense		1,726,409		753,976		—		2,480,385
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(287,722)		(287,722)
Interest expense		—		—		410,317		410,317
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(1,159,582)	$	(587,554)	$	(6,734,202)	$	(8,481,338)

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The Company’s results of operations by reportable segment for the three months ended September 30, 2024, are summarized as follows:


	Prescription		Medical
For the Three Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	858,063	$	718,303	$	—	$	1,576,366
Cost of goods sold		48,707		238,298		—		287,005
Selling, general and administrative expenses		471,669		600,565		1,229,071		2,301,305
Research and development expenses		588,355		—		—		588,355
Depreciation and amortization expense		521,597		217,852		—		739,449
Change in fair value of derivative liability		—		—		(202,000)		(202,000)
Interest income		—		—		(75,817)		(75,817)
Interest expense		—		—		158,730		158,730
Net loss	$	(772,265)	$	(338,412)	$	(1,109,984)	$	(2,220,661)

The Company’s results of operations by reportable segment for the three months ended September 30, 2023, are summarized as follows:


	Prescription		Medical
For the Three Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	925,759	$	748,898	$	—	$	1,674,657
Cost of goods sold		85,388		323,087		—		408,475
Selling, general and administrative expenses		251,674		493,447		1,256,814		2,001,935
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		369,505		19,588		—		389,093
Depreciation and amortization expense		575,470		251,325		—		826,795
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(168,481)		(168,481)
Interest expense		—		—		131,351		131,351
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(356,278)	$	(338,549)	$	(3,854,681)	$	(4,549,508)

The following table reflects net sales by geographic region for the three and nine months ended September 30, 2024, and 2023:


	For the Three Months Ended				For the Nine Months Ended
	September 30,				September 30,
Net sales	2024		2023		2024		2023
United States	$	1,397,969	$	1,496,988	$	3,682,248	$	5,253,587
International		178,397		177,669		704,392		933,051
	$	1,576,366	$	1,674,657	$	4,386,640	$	6,186,638

No individual country other than the United States accounted for 10% of total sales for the three and nine months ended September 30, 2024, and 2023.

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of September 30, 2024, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	3,410,499	$	3,415,388	$	6,825,887
Total segment assets	$	15,640,046	$	5,053,584	$	20,693,630

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The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2023, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	4,903,749	$	4,067,988	$	8,971,737
Total segment assets	$	27,891,180	$	5,904,615	$	33,795,795

16) Private Placement

On July 13, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”), pursuant to which the Company agreed to sell in a private placement to the Investors (i) an aggregate of 15,000 shares of the Company’s newly-designated Series A Convertible Preferred Stock, with a par value of $0.0001 per share and a stated value (“Stated Value”) of $1,000 per share (the “Series A Preferred Stock”), initially convertible into up to 6,666,668 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) at an initial conversion price of $2.25 per share (the “Series A Preferred Shares”), and (ii) warrants to acquire up to an aggregate of 6,666,668 shares of Common Stock (the “Warrants”) at an initial exercise price of $2.25 per share (collectively, the “Private Placement”). Pursuant to the terms of the Certificate of Designations of Series A Convertible Preferred Stock (the “Certificate of Designations”) and the Warrants, each of the Conversion Price (as defined below) and the exercise price and the number of shares underlying the Warrants is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). As of September 30, 2024, the Conversion Price and the exercise price of the Warrants was equal to $2.25 per share. On March 21, 2024, the Company entered into Omnibus Waiver and Amendments with the investors named therein, effective December 31, 2023 (the “Waiver and Amendment”). The Waiver and Amendment provides that certain equity awards granted to directors, officers, employees of the Company under the Company’s 2020 Omnibus Incentive Compensation Plan are deemed to constitute “Excluded Securities” under the Transaction Documents (as such term is defined in the Purchase Agreement) and waives the applicability of certain other provisions of the Transaction Documents with respect to such grants. The Waiver and Amendment also amended certain terms of the Warrants relating to the rights of the holders of the Warrants to provide that, in the event of a Fundamental Transaction (as defined in the Warrants) that is not within the Company’s control, including not approved by the Company’s Board of Directors, the holder of a Warrant shall only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of such Warrant, that is being offered and paid to the holders of the Company’s Common Stock in connection with the Fundamental Transaction.

Series A Preferred Stock

The terms of the Series A Preferred Shares are as set forth in the form of Certificate of Designations. The Series A Preferred Shares will be convertible into shares of Common Stock (the “Conversion Shares”) at the election of the holder at any time at an initial conversion price of $2.25 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). The Company is required to redeem the Series A Preferred Shares in 13 equal monthly installments, commencing on November 1, 2023. The amortization payments due upon such redemptions are payable, at the Company’s election, in cash at 107% of the Installment Redemption Amount (as defined in the Certificate of Designations), or subject to certain limitations, in shares of common stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) the lower of $0.396, which is 20% of the “Minimum Price” (as defined in Nasdaq Stock Market Rule 5635) on the date of the Nasdaq Stockholder Approval (as defined below) or such lower amount as permitted, from time to time, by the Nasdaq Stock Market, subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations or other similar events. The Company may require holders to convert their Series A Preferred Shares into Conversion Shares if the closing price of the Common Stock exceeds $6.75 per share (subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations or other similar events) for 20 consecutive trading days and the daily dollar trading volume of the Common Stock exceeds two million dollars ($2,000,000) per day during the same period and certain equity conditions described in the Certificate of Designations are satisfied.

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The holders of the Series A Preferred Shares are entitled to dividends of 8% per annum, compounded monthly, which are payable, at the Company’s option, in cash or shares of Common Stock, or in a combination thereof, in accordance with the terms of the Certificate of Designations. On September 29, 2023, the Company filed an amendment to the Certificate of Designations with the Secretary of State of the State of Delaware, pursuant to which the terms of the Series A Preferred Stock were amended to permit certain additional procedures for the payment of redemptions and conversions Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series A Preferred Shares will accrue dividends at the rate of 15% per annum. In connection with a Triggering Event, each holder of Series A Preferred Shares will be able to require us to redeem in cash any or all of the holder’s Series A Preferred Shares at a premium set forth in the Certificate of Designations. Upon conversion or redemption, the holders of the Series A Preferred Shares are also entitled to receive a dividend make-whole payment. Prior to the Certificate of Amendment (defined below), the holders of the Series A Preferred Shares did not have voting rights, other than with respect to certain matters affecting the rights of the Series A Preferred Shares.

On October 11, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing a Certificate of Amendment to the Certificate of Designations (the “October 2024 Certificate of Amendment”) with the Secretary of State of the State of Delaware. The October 2024 Certificate of Amendment amends the Certificate of Designations to, among other things, provide that, except as required by applicable law, the holders of the Series A Preferred Stock will be entitled to vote with holders of the Common Stock on an as converted basis, with the number of votes to which each holder of Series A Preferred Stock is entitled to be determined by dividing the Stated Value by a conversion price equal to $2.25 per share, which was the “Minimum Price” (as defined in Nasdaq Listing Rule 5635(d)) applicable immediately before the execution and delivery of the Purchase Agreement, subject to certain beneficial ownership limitations and adjustments for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions, as set forth in the Certificate of Designations. The October 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of October 11, 2024.

On November 13, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing a Certificate of Amendment to the Certificate of Designations (the “November 2024 Certificate of Amendment”) with the Secretary of State of the State of Delaware, (ii) defer any payment amounts that have accrued and that are unpaid as of November 13, 2024 pursuant to the Certificate of Designations, to January 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company’s failure to pay such outstanding amounts. The November 2024 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to January 15, 2025, (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations), and (iii) adds an additional restrictive covenant to the Certificate of Designations requiring the Company from November 13, 2024 until January 15, 2025, to maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $1,500,000. The November 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of November 13, 2024.

During December 2023, the Company issued as equity awards, shares of Common Stock and options to purchase shares of Common Stock representing an aggregate of 348,711 shares of Common Stock and shares of Common Stock issuable upon exercise of the options to certain directors, officers, and employees of the Company, representing an aggregate number of shares of Common Stock in excess of 5% of the shares of Common Stock issued and outstanding immediately prior to the date of the Purchase Agreement (the “December Issuances”). Under the terms of the Certificate of Designations, the Conversion Price of the Series A Preferred Shares was required to be adjusted as a result of the December Issuances.

The Series A Preferred Shares were determined to be more akin to a debt-like host than an equity-like host. The Company identified the following embedded features that are not clearly and closely related to the debt host instrument: 1) make-whole interest upon a contingent redemption event, 2) make-whole interest upon a conversion event, 3) an installment redemption upon an Equity Conditions Failure (as defined in the Certificate of Designation), and 4) variable share-settled installment conversion. These features were bundled together, assigned probabilities of being affected and measured at fair value. Subsequent changes in fair value of these features are recognized in the unaudited condensed consolidated statements of operations.

During the three and nine months ended September 30, 2024, the Company recorded a gain of $202,000 and $3,550,000, respectively, related to the change in fair value of the derivative liability which is recorded in other income (expense) on the unaudited consolidated statements of operations. The Company estimated the $0 fair value of the bifurcated embedded derivative at September 30, 2024 using a Monte Carlo simulation model, with the following inputs the fair value of the Company’s Common Stock of $0.36 on the valuation date, estimated equity volatility of 60.0%, estimated traded volume volatility of 230.0%, the time to maturity of 0.17 years, risk free rate

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of 4.83%, a discounted market interest rate of 12.5%, dividend rate of 8.0%, a penalty dividend rate of 15.0%, and probability of default of 4.0%.

As of September 30, 2024, the Company has notified the investors of its intention to redeem the upcoming installment due in cash and recorded a liability of $1,144,582 representing the cash payable to investors which includes $965,006 of the stated value of the Series A Preferred Shares, $104,693 of accrued dividends payable, and $74,883 for the cash premium which was recognized as a deemed dividend.

During the three months ended September 30, 2024, the Company experienced an Equity Conditions Failure in which the Company’s average stock price during the Installment Conversion Price Measuring Period (as defined in the Certificate of Designations) corresponding to the September 1, 2024, and October 1, 2024, installments (the “Affected Installments”) was below the Floor Price (as defined in the Certificate of Designations) (the “Floor Price Condition”). As a result of the Floor Price Condition, the Company is required to redeem the Affected Installments as well as any previously deferred installment amounts at a 125% premium. Accordingly, the Company recorded a liability for penalty premiums totaling $598,336 as of September 30, 2024, related to the Floor Price Condition, which is included in Accrued Series A Convertible Preferred payments payable on the accompanying condensed consolidated balance sheet, and a corresponding reduction in additional paid-in capital for the three and nine months ended September 30, 2024, which was recognized as a deemed dividend.

During the three months ended September 30, 2024, the Company redeemed a total of 3,000 Series A Preferred Shares in cash for $2,389,478 and issued 580,348 shares of Common Stock pursuant to the terms of the Certificate of Designations, equal to $232,143. During the three months ended September 30, 2024, the Company recognized a total of $453,359 of preferred dividends consisting of $236,821 of preferred dividends at the stated dividend rate, and $216,538 of cash premiums recognized as deemed dividends.

During the nine months ended September 30, 2024, the Company redeemed a total of 8,983 Series A Preferred Shares for cash equal to $5,089,417 and issued 6,563,523 shares of Common Stock, elected pursuant to the terms of the Certificate of Designations, equal to $6,586,033. During the nine months ended September 30, 2024, the Company recognized a total of $1,265,662 of preferred dividends consisting of $991,783 of preferred dividends at the stated dividend rate, and $273,879 of cash premium recognized as a deemed dividend.

17) Fair Value Measurements

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the quarter ended September 30, 2024. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of September 30, 2024, due to their short-term nature. The fair value of the bifurcated embedded derivative related to the convertible preferred stock was estimated using a Monte Carlo simulation model, which uses as inputs the fair value of the Company’s Common Stock and estimates for the equity volatility and traded volume volatility of the Company’s Common Stock, the time to maturity of the convertible preferred stock, the risk-free interest rate for a period that approximates the time to maturity, dividend rate, a penalty dividend rate, and the Company’s probability of default.

Fair Value on a Recurring Basis

The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the warrant liability and bifurcated embedded derivatives represent Level 3 measurements. The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis at September 30, 2024, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:


		September 30,
Description	Level	2024
Liabilities:
Bifurcated embedded derivative liability	3	$	—

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The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis:


Balance on December 31, 2023	$	3,550,000
Change in fair value of bifurcated embedded derivative		(3,550,000)
Balance on September 30, 2024	$	—

18) Restatement of Previously Issued Financial Statements

The Company identified certain errors related to the omission of the accretion of the Company’s Series A convertible preferred stock (the “Preferred Stock”) to its redemption value that was recognized during the three months ended September 30, 2023, from the calculation of net loss per share, which resulted in the following misstatements in the financial statements as of and for the three and nine months ended September 30, 2023:

●

Omission of the Preferred Stock accretion in the calculation of net income attributable to common stockholders as presented on the condensed consolidated statements of operations for the three and nine months ended September 30, 2023, and a resulting error in the calculation of basic and diluted earnings per share.

The Company’s prior accounting for the Preferred Stock accretion did not have any effect on the Company’s previously reported cash flows or cash.

The following tables summarize the effect of the restatement on each financial statement line item as of the dates, and for the period, indicated:

For the three months ended, September 30, 2023:


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(4,888,740)		(1,153,846)		(6,042,586)
Net loss per share, basic and diluted	$	(2.31)	$	(0.54)	$	(2.85)

For the nine months ended, September 30, 2023:


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(8,820,570)		(1,153,846)		(9,974,416)
Net loss per share, basic and diluted	$	(4.18)	$	(0.55)	$	(4.73)


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF CASH FLOWS	2023				2023
	As Reported		Adjustment		As Restated
Supplemental disclosure of cash flows information
Accretion of Series A convertible preferred stock to redemption value	$	1,250,000	$	(96,154)	$	1,153,846

19) Subsequent Events

On October 1, 2024, the Company failed to make the required payment due pursuant to the Note and related Security Agreement with Vivus in the amount of $0.5 million, constituting an Event of Default (as defined in the Note) under the Note and Security Agreement. Pursuant to the terms of the Note, upon and at all times after the occurrence of any Event of Default, all principal outstanding under the Note will bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note is paid (regardless of whether any default is waived or cured). Further, Vivus, at its option, may declare any or all amounts owing under the

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Note (whether principal, interest, or otherwise), to be due and payable, and, subject to the terms of the Security Agreement, foreclose on the Collateral, which includes the Company’s Stendra® API and products and the Company’s rights under the License Agreement. As a result of the Event of Default, the Company accrued an additional $50,000 of interest expense.

On October 1, 2024, John Shulman, who served as a member of the Board, tendered his resignation from his role as director of the Company, effective as of October 1, 2024. Mr. Shulman’s resignation from the Board was not in connection with any disagreement between Mr. Shulman and the Company, its management, the Board or any committee of the Board on any matter relating to the Company’s operations, policies or practices, or any other matter.

On October 2, 2024, Greg Bradley, who served as a member of the Board tendered his resignation from his role as director of the Company, effective as of October 2, 2024. Mr. Bradley’s resignation from the Board was not in connection with any disagreement between Mr. Bradley and the Company, its management, the Board or any committee of the Board on any matter relating to the Company’s operations, policies or practices, or any other matter.

On October 11, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing a Certificate of Amendment with the Secretary of State of the State of Delaware . The October 2024 Certificate of Amendment amends the Certificate of Designations to, among other things, provide that, except as required by applicable law, the holders of the Series A Preferred Stock will be entitled to vote with holders of the Common Stock on an as converted basis, with the number of votes to which each holder of Series A Preferred Stock is entitled to be determined by dividing the Stated Value by a conversion price equal to $2.25 per share, which was the “Minimum Price” (as defined in Nasdaq Listing Rule 5635(d)) applicable immediately before the execution and delivery of the Purchase Agreement, subject to certain beneficial ownership limitations and adjustments for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions, as set forth in the Certificate of Designations. The October 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of October 11, 2024.

On October 16, 2024, the Company entered into an Offer Letter Amendment (the “Amendment”), effective as of October 16, 2024 (the “Effective Date”), with Fady Boctor (“Boctor”), the Company’s President and Chief Commercial Officer, for the purpose of amending that certain Employment Offer Letter, effective February 19, 2021, by and between the Company and Boctor (the “Offer Letter”). The Amendment, among other things: (i) allows Boctor to engage in other consulting or employment activities for direct or indirect remuneration, so long as such engagement or service does not create a conflict of interest with, or interfere with the performance of, his duties under the Offer Letter or conflict with any covenants with the Company; (ii) amends the term of the Offer Letter, which shall terminate on December 31, 2024; and (iii) adjusts Boctor’s base salary from an annual rate of $350,000 to an annual rate of $280,000 effective as of the Effective Date.

In October 2024, the Company experienced an Equity Conditions Failure in which the Company’s average stock price during the Installment Conversion Price Measuring Period relating to the November 1, 2024, installment (the “November Installment”) was below the Floor Price (the “November Installment Floor Price Condition”). As a result of the November Installment Floor Price Condition, the Company is required to redeem the November Installment at a 125% premium. Accordingly, the Company incurred penalty premiums totaling $207,201 related to the November Installment Floor Price Condition.

On November 13, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing the November 2024 Certificate of Amendment with the Secretary of State of the State of Delaware, (ii) defer any payment amounts that have accrued and that are unpaid as of November 13, 2024 pursuant to the Certificate of Designations, to January 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company’s failure to pay such outstanding amounts. The November 2024 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to January 15, 2025, (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations), and (iii) adds an additional restrictive covenant to the Certificate of Designations requiring the Company from November 13, 2024 until January 15, 2025, to maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $1,500,000. The November 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of November 13, 2024.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is designed to provide a reader of Petros’ financial statements with a narrative from the perspective of management on the Company’s financial condition, results of operations, liquidity and certain other factors that may affect future results. In certain instances, parenthetical references are made to relevant sections of the Notes to Condensed Consolidated Financial Statements to direct the reader to a further detailed discussion. This section should be read in conjunction with the Consolidated Financial Statements and Supplementary Data included in this Quarterly Report on Form 10-Q. This MD&A contains forward-looking statements reflecting Petros’ current expectations, whose actual outcomes involve risks and uncertainties. Actual results and the timing of events may differ materially from those stated in or implied by these forward-looking statements due to a number of factors, including those discussed in the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” contained in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as amended.

Overview

Petros is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Petros consists of wholly owned subsidiaries, Metuchen Pharmaceuticals, LLC (“Metuchen”), Timm Medical Technologies, Inc. (“Timm Medical”), and Pos-T-Vac, LLC (“PTV”). On September 30, 2016, the Company entered into a License and Commercialization Agreement (the “License Agreement”) with Vivus, Inc (“Vivus”) to purchase and receive the license for the commercialization and development of Stendra® for a one-time fee of $70 million. The License Agreement gives the Company the right to sell Stendra® in the U.S and its territories, Canada, South America, and India. Stendra® is a U.S. Food and Drug Administration (“FDA”) approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction (“ED”) and is the only patent protected PDE-5 inhibitor on the market in the US. Stendra® offers the ED therapeutic landscape a valuable addition as an oral ED therapy that may be taken as early as approximately 15 minutes prior to sexual engagement, with or without food when using the 100mg or 200mg dosing (does not apply to 50mg dosing). Petros is also currently conducting non-clinical consumer studies in connection with the contemplated pursuit of FDA approval for Stendra® for Non-Prescription / Over-The-Counter (“OTC”) use in treating ED.

In addition to Stendra®, Petros’ ED portfolio also includes external penile rigidity devices, namely Vacuum Erection Devices (“VEDs and related accessories”), which are sold domestically and internationally.

Licensing and Distribution

The Company acquired the rights to Stendra® avanafil on September 30, 2016, when it entered into the License Agreement with Vivus to purchase and receive the license for the commercialization and exploitation of Stendra® avanafil for a one-time fee of $70 million. The License Agreement gives the Company the exclusive right to sell avanafil in the U.S. and its territories, as well as Canada, South America, and India. In December 2000, Vivus originally was granted the license from Mitsubishi Tanabe Pharma Corporation (“MTPC”) to develop, market, and manufacture Stendra®. Stendra® was approved by the FDA in April 2012 to treat ED.

The Company will pay MTPC a royalty of 5% on the first $500 million of net sales and 6% of net sales thereafter until the expiration of the applicable patent in a particular country. The last scheduled patent expiration is in April 2025. In consideration for the trademark assignment and the use of the trademarks associated with Stendra® and the Vivus technology, the Company shall (a) during the first, second, and third years following the expiration of the royalty period in a particular country in the Company’s territory, pay to Vivus a royalty equal to 2% of the net sales of Stendra® in such territory; and (b) following the fourth and fifth years following the expiration of the royalty period in such territory, pay to Vivus a royalty equal to 1% of the net sales of Stendra® in such territory. After the royalty period, no further royalties shall be owed with respect to net sales of Stendra® in such territory. In addition, the Company will be responsible for a pro-rata portion of a one-time $6 million milestone payment to be paid once $250 million in sales has been reached on the separate revenue stream of Stendra® during any calendar year.

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In connection with the License Agreement, the Company and Vivus also entered into a Supply Agreement on September 30, 2016, which has since been terminated, effective as of September 30, 2021. Following the termination of the Vivus Supply Agreement, Petros, through its subsidiary Metuchen, entered into a Technology Transfer Service Agreement on January 20, 2022, with Patheon Pharmaceuticals Inc., part of Thermo Fisher Scientific (“Patheon”), pursuant to which the Company and Patheon agreed to collaborate as strategic partners for commercial production of Stendra® tablets at Patheon’s facilities in Cincinnati, Ohio. Under the agreement, Patheon or one of its affiliates will provide pharmaceutical development and technology transfer services in order to establish and validate its ability to manufacture supply of the Company’s Stendra® product. Any commercial sale of product manufactured during the performance of the agreement must be subject to a subsequent commercial manufacturing services agreement (with associated quality agreement) between the parties before it can be offered for commercial sale.

The license agreement between MTPC and Vivus contains certain termination rights that will allow MTPC to terminate the agreement if Vivus were to breach any of the terms of the MTPC License or become insolvent or bankrupt. In the event that MTPC terminates the MTPC License with Vivus because of any contractual breach the Company has step-in rights with MTPC, which would allow the Company to continue to sell Stendra®.

On March 27, 2018, the Company entered into a Sublicense Agreement with Acerus Pharmaceuticals Corporation (“Acerus”) whereby the Company granted to Acerus an exclusive sublicense in Canada for, among other things, the development and commercialization of Stendra® avanafil for a one-time fee of $100,000. The Company was entitled to receive an additional fee of $400,000 if Stendra® is approved by Canadian regulators, as well as commercial milestone payments and royalty fees of 12% of net sales. However, in April 2020 Health Canada issued a Notice of Deficiency (“NOD”) against the New Drug Submission. Metuchen and Acerus attempted to renegotiate modified terms to the sub-license agreement and the viability of a pathway required to address the deficiency noted by Health Canada but to no avail. In March of 2023, Acerus announced commencement of a court - approved (issued by the Ontario Superior Court of Justice and granted by the U.S. Bankruptcy Court for the District of Delaware) sale and investment solicitation process for all or part of its assets. The Sublicense Agreement with Acerus has therefore been halted indefinitely.

Vivus Settlement Agreement, Promissory Note and the Security Agreement

On January 18, 2022, Petros (through its wholly-owned subsidiary) and Vivus entered into a Settlement Agreement (the “Vivus Settlement Agreement”) related to the minimum purchase requirements under the Vivus Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company’s Stendra® product that were delivered to the third-party retailer and later returned. In connection with the Vivus Settlement Agreement, Petros retained approximately $7.3 million of API inventory (representing the 2018 and 2019 minimum purchase requirements) out of approximately $12.4 million due under the Vivus Supply Agreement, in conjunction with forgiveness of approximately $4.25 million of current liabilities relating to returned goods and minimum purchase commitments. In exchange for the API and reduction of current liabilities, Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the principal amount of $10,201,758. The parties also entered into a Security Agreement to secure Petros’ obligations under the Note. The Company recorded the impact of this transaction, including the gain in the first quarter of 2022.

In addition to the payments to be made in accordance with the Note, the Company further agreed in the Vivus Settlement Agreement to (i) grant to Vivus a right of first refusal to provide certain types of debt and convertible equity (but not preferred equity) financing issued by or to Metuchen (including any subsidiaries and intermediaries) until the Note is paid in full, and (ii) undertake to make certain regulatory submissions to effectuate Vivus’ ability to exercise its rights under the License Agreement. On January 18, 2022, the Company made a prepayment of the obligations under the Note in the amount of $900,000, and a payment of $1,542,904 with respect to a purchase order made in 2021 to Vivus. In consideration of these payments and upon the Company’s satisfaction of certain regulatory submissions. Vivus released 50% of the quantity of bulk Stendra® tablets under the Company’s existing open purchase order (the “Open Purchase Order”) being held by Vivus, which represented approximately a six-month supply of inventory. Pursuant to the Vivus Settlement Agreement, Vivus released the remaining 50% of the quantity of bulk Stendra® tablets under the Open Purchase Order, later during the first quarter of 2022, upon the Company’s satisfaction of the remaining regulatory submission requirements.

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Under the terms of the Note, the principal amount of $10,201,758 is payable in consecutive quarterly installments beginning on April 1, 2022, through January 1, 2027. Interest on the principal amount will accrue at a rate of 6% per year until the principal is repaid in full and is due and payable, in arrears, on the first day of each January, April, July, and October of each calendar year, commencing on April 1, 2022. The Company may prepay the Note, in whole or in part, at any time, with no premium or penalty. Defaults under the Security Agreement require all principal amounts outstanding under the Note at the time of the default to bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note has been paid (regardless of whether any default is waived or cured). If the Note is placed in the hands of any attorney for collection, or if it is collected through any legal proceeding at law or in equity or in bankruptcy, receivership, or other court proceedings, the Company will also be required to pay all costs of collection including, but not limited to, court costs and attorneys’ fees. Pursuant to the Security Agreement, dated January 18, 2022, the Company granted to Vivus a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement. The Security Agreement contains customary events of default. For the nine months ended September 30, 2024, and 2023, the Company paid Vivus $1.0 million and $1.5 million, respectively. As of September 30, 2024, the principal balance on the Note is $7.2 million.

Nasdaq Listing Requirements

On May 15, 2024, we received notice from the Listing Qualifications Staff of Nasdaq (the “Staff”) indicating that, based upon the closing bid price of our Common Stock for the 30 consecutive business day period between April 3, 2024, through May 14, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). The letter also indicated that we were provided with a compliance period until November 11, 2024, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s Common Stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency Nasdaq will provide notice that the Company’s Common Stock will be subject to delisting. There can be no assurance that the Nasdaq staff would grant the Company’s request for continued listing subsequent to any delisting notification. In the event of such a notification, the Company may appeal the Nasdaq staff’s determination to delist its securities.

Critical Accounting Estimates

The preparation of unaudited condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions and estimates that affect the amounts reported. Note 2, “Summary of Significant Accounting Policies” of the Notes to Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q and in the Notes to Consolidated Financial Statements in Part II, Item 8 of the 2023 Form 10-K describe the significant accounting policies and methods used in the preparation of the Company’s unaudited condensed consolidated financial statements. There have been no material changes to the Company’s critical accounting estimates since the 2023 Form 10-K.

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Nine Months Ended September 30, 2024, and 2023 (Unaudited)

The following table sets forth a summary of our statements of operations for the nine months ended September 30, 2024, and 2023:


	For the Nine Months Ended September 30,
	2024		2023
Net sales	$	4,386,640	$	6,186,638
Cost of sales		947,946		1,473,073
Gross profit		3,438,694		4,713,565

Operating expenses:
Selling, general and administrative		7,299,391		6,382,166
Warrant Issuance Costs		—		2,855,000
Research and development		2,513,105		1,574,760
Depreciation and amortization expense		2,175,126		2,480,385
Total operating expenses		11,987,622		13,292,311

Loss from operations		(8,548,928)		(8,578,746)

Change in fair value of derivative liability		3,550,000		(430,000)
Change in fair value of warrant liability		—		11,739,000
Interest income		347,028		287,722
Interest expense, promissory note		(393,450)		(410,317)
Loss on issuance of Series A Preferred Stock		—		(11,088,997)

Total Other income (expense)		3,503,578		97,408

Loss before income taxes		(5,045,350)		(8,481,338)

Income tax expense		—		—

Net loss	$	(5,045,350)	$	(8,481,338)

Net Sales

Net sales for the nine months ended September 30, 2024, were $4,386,640, composed of $2,086,180 of net sales from Prescription Medicines and net sales of $2,300,460 from Medical Devices.

Net sales for the nine months ended September 30, 2023, were $6,186,638, composed of $3,416,444 of net sales from Prescription Medicines and net sales of $2,770,194 from Medical Devices.

For the nine months ended September 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers that represented approximately 28%, 25%, and 14% of total gross billings, respectively. Gross billings is a non-GAAP financial measure. For a reconciliation of net sales to gross billings, see the section titled “Reconciliation of Non-GAAP Financial Measures” below.

For the nine months ended September 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers that represented approximately 23%, 19%, and 17% of total gross billings. Gross billings is a non-GAAP financial measure. For a reconciliation of net sales to gross billings, see the section titled “Reconciliation of Non-GAAP Financial Measures” below.

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Prescription Medicines sales consist of sales of Stendra® in the U.S. for the treatment of male ED. Stendra® is primarily sold directly to three main customers, as described above, which collectively accounted for approximately 95% of Stendra® net sales for the nine months ended September 30, 2024. Individually, sales to the three main customers, accounted for 40%, 35%, and 20% of Stendra® gross billings for the nine months ended September 30, 2024.

Medical Device sales consist of domestic and international sales of men’s health products for the treatment of ED. The men’s health products do not require a prescription and include VEDs and related accessories.

Net sales were $1,799,998 or 29% lower during the nine months ended September 30, 2024, compared to the same period in 2023 consisting of a $1,330,264 decrease in the net sales of Stendra® and a $469,734 decrease in Medical Device Sales. The decrease in net sales of Stendra® was substantially due to decreased wholesaler sales due to decreased demand and decreased related sales allowances stemming from a reduction in promotional activities. The decrease in net sales for Medical Devices included a decrease in domestic and international sales of VED systems.

Cost of Sales

Cost of sales for the nine months ended September 30, 2024, were $947,946, composed of $194,035 of cost of sales for our Prescription Medicines segment and $753,911 for our Medical Devices segment.

Cost of sales for the nine months ended September 30, 2023, were $1,473,073, composed of $343,109 of cost of sales for our Prescription Medicines segment and $1,129,964 for our Medical Devices segment.

Cost of sales for the Prescription Medicine segment for the nine months ended September 30, 2024, consisted of 38% third-party product cost of sales, 54% royalty expenses, and 8% 3PL order fulfillment and shipping expenses.

Cost of sales for the Medical Device segment for the nine months ended September 30, 2024, consisted of 83% raw materials and 17% production labor.

Cost of sales decreased by $525,127 or 36% during the nine months ended September 30, 2024, compared to the same period in 2023. For the nine months ended September 30, 2024, and September 30, 2023, cost of sales as a percentage of net sales was 22% and 24%, respectively.

Gross Profit

Gross profit for the nine months ended September 30, 2024, was $3,438,694 or 78%, composed of $1,892,145 of gross profit from Prescription Medicines and $1,546,549 from Medical Devices. Gross profit for the nine months ended September 30, 2023, was 4,713,565, or 76% of net sales, composed of $3,073,335 of gross profit from Prescription Medicines and $1,640,230 from Medical Devices. The increase in gross profit was driven by the factors noted above.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses for the nine months ended September 30, 2024, were $7,299,391, composed of $1,774,594 of selling, general and administrative expenses of our Prescription Medicines segment, $1,673,122 of selling, general and administrative expenses of our Medical Devices segment and $3,851,675 of general corporate expenses.

Selling, general and administrative expenses for the nine months ended September 30, 2023, were $6,382,166, composed of $1,006,666 of selling, general and administrative expenses of our Prescription Medicines segment, $1,398,890 of selling, general and administrative expenses of our Medical Devices segment and $3,976,610 of general corporate expenses.

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Selling, general and administrative expenses for both segments include selling, marketing and regulatory expenses. Unallocated general corporate expenses include costs that were not specific to a particular segment but are general to the group, including expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees and other similar corporate expenses.

Selling, general and administrative expenses increased by $917,225 or 14% during the nine months ended September 30, 2024, compared to the same period in 2023. Increased selling general and administrative expenses were primarily driven by a waiver of FY 23 PDUFA fees by the FDA resulting in a $937,652 increase in PDUFA expense and increased professional service fees of $213,884 and increased franchise taxes of $36,301 partially offset by decreased insurance expenses of $202,443 and decreased other operating expenses of $68,169.

Warrant issuance costs

For the nine months ended September 30, 2024, and September 30, 2023, respectively, the Company recorded warrant issuance costs of $0 and $2.9 million associated with the Private Placement (as defined herein).

Research and development

Research and development expenses for the nine months ended September 30, 2024, were $2,513,105, composed of $2,513,105 for our Prescription Medicines segment and $0 for our Medical Devices segment, respectively.

Research and development expenses for the nine months ended September 30, 2023, were $1,574,760, composed of $1,499,842 for our Prescription Medicines segment and $74,918 for our Medical Devices segment, respectively.

Research and development expenses for the Prescription Medicines segment for the nine months ended September 30, 2024, are composed of $2,157,786 for clinical development, $323,867 for consulting fees, and $31,452 for legal fees related to the Company’s OTC Strategies related to Stendra®. Research and development expenses for the Prescription Medicines segment for the nine months ended September 30, 2023, are composed of $836,507 for clinical development and $436,222 for consulting fees related to the Company’s OTC Strategies related to Stendra®; $200,000 for upfront licensing fees and $24,620 for consulting fees related to the H100 license acquired in March 2020, which was later terminated during the second quarter of 2023, and $2,493 related to the Company’s tech transfer of its manufacturing process.

Research and development expenses for the Medical Devices segment for the nine months ended September 30, 2024, were $0. Research and development expenses for the Medical Devices segment for the nine months ended September 30, 2023, are composed of $74,918 for license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies.

Research and development expenses increased by $938,345 or 60% during the nine months ended September 30, 2024, compared to the same period in 2023. Increased research and development expenses were primarily driven by increased clinical development expenses related to the Company’s OTC strategies related to Stendra®.

Depreciation and amortization

Depreciation and amortization expenses for the nine months ended September 30, 2024, were $2,175,126, composed of $1,522,207 of depreciation and amortization expenses of our Prescription Medicines segment and $652,919 of depreciation and amortization expenses of our Medical Devices segment.

Depreciation and amortization expenses for the nine months ended September 30, 2023, were $2,480,385, composed of $1,726,409 of depreciation and amortization expenses of our Prescription Medicines segment and $753,976 of depreciation and amortization expenses of our Medical Devices segment.

Prescription Medicines depreciation and amortization consists primarily of the amortization of the intangible assets related to Stendra® over its estimated useful life of 10 years. Medical Devices depreciation and amortization primarily consists of the amortization of the intangible assets related to Timm Medical and PTV over their estimated useful life of 12 years. The decrease in total depreciation and amortization results from the use of the accelerated method of amortization.

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Change in fair value of derivative liability

For the nine months ended September 30, 2024, and September 30, 2023, the Company recorded a gain of $3.6 million and a loss of $0.4 million, respectively, for the change in fair value of the derivative liability. The gains and losses related to the change in the fair value of a derivative liability established for certain bifurcated features of the Series A Preferred Stock issued in the Private Placement (as defined herein).

Change in fair value of warrant liability

For the nine months ended September 30, 2024, and September 30, 2023, respectively, the Company recorded a gain of $0 and $11.7 million for the change in fair value of the warrant liability. The gain related to the decrease in the fair value of warrants issued in the Private Placement (as defined herein) which were classified as liabilities in accordance with ASC 815.

Interest Income

Interest income for the nine months ended September 30, 2024, and 2023, was $347,028 and $287,722, respectively. Petros invested its cash in money market securities during 2024 and 2023.

Interest Expense, Promissory Note

In January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 in connection with the Vivus Settlement Agreement. Interest expense, promissory note for the nine months ended September 30, 2024, and 2023, was $393,450 and $410,317, respectively.

Loss on issuance of Series A Preferred Stock

As the fair value of the liabilities required to be subsequently measured at fair value exceeded the net proceeds received, for nine months September 30, 2023, the Company recognized the excess of the fair value over the net proceeds received as a loss upon issuance of preferred stock of $11.1 million, which is included in other income (expense) in the condensed consolidated statement of operations. No similar losses were recognized during the nine months ended September 30, 2024, as no issuances of this nature occurred.

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Three Months Ended September 30, 2024, and 2023 (Unaudited)

The following table sets forth a summary of our statements of operations for the three months ended September 30, 2024, and 2023:


	For the Three Months Ended September 30,
	2024		2023
Net sales	$	1,576,366	$	1,674,657
Cost of sales		287,005		408,475
Gross profit		1,289,361		1,266,182

Operating expenses:
Selling, general and administrative		2,301,305		2,001,935
Warrant issuance costs		—		2,855,000
Research and development		588,355		389,093
Depreciation and amortization expense		739,449		826,795
Total operating expenses		3,629,109		6,072,823

Loss from operations		(2,339,748)		(4,806,641)

Change in fair value of derivative liability		202,000		(430,000)
Change in fair value of warrant liability		—		11,739,000
Interest income		75,817		168,481
Interest expense, promissory note		(158,730)		(131,351)
Loss on issuance of Series A Preferred Stock		—		(11,088,997)

Total Other income (expense)		119,087		257,133

Loss before income taxes		(2,220,661)		(4,549,508)

Income tax expense		—		—

Net loss	$	(2,220,661)	$	(4,549,508)

Net Sales

Net sales for the three months ended September 30, 2024, were $1,576,366, composed of $858,063 of net sales from Prescription Medicines and net sales of $718,303 from Medical Devices.

Net sales for the three months ended September 30, 2023, were $1,674,657, composed of $925,759 of net sales from Prescription Medicines and net sales of $748,898 from Medical Devices.

For the three months ended September 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers that represented approximately 30%, 25%, and 14% of total gross billings, respectively. Gross billings is a non-GAAP financial measure. For a reconciliation of net sales to gross billings, see the section titled “Reconciliation of Non-GAAP Financial Measures” below.

For the three months ended September 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers that represented approximately 24%, 21%, and 18% of total gross billings. Gross billings is a non-GAAP financial measure. For a reconciliation of net sales to gross billings, see the section titled “Reconciliation of Non-GAAP Financial Measures” below.

Prescription Medicines sales consist of sales of Stendra® in the U.S. for the treatment of male ED. Stendra® is primarily sold directly to three main customers, as described above, which collectively accounted for approximately 94% of Stendra® net sales for the three months ended September 30, 2024. Individually, sales to the three main customers, accounted for 41%, 34%, and 19% of Stendra® gross billings for the three months ended September 30, 2024.

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Net sales were $98,291 or 6% lower during the three months ended September 30, 2024, compared to the same period in 2023 consisting of a $67,697 decrease in the net sales of Stendra® and a $30,594 decrease in Medical Device Sales. The decrease in net sales of Stendra® was substantially due to decreased wholesaler sales due to decreased demand and decreased related sales allowances stemming from a reduction in promotional activities. The decrease in net sales for Medical Devices was substantially due to decrease in domestic sales of VED systems.

Cost of Sales

Cost of sales for the three months ended September 30, 2024, were $287,005, composed of $48,707 of cost of sales for our Prescription Medicines segment and $238,298 for our Medical Devices segment.

Cost of sales for the three months ended September 30, 2023, were $408,475, composed of $85,388 of cost of sales for our Prescription Medicines segment and $323,087 for our Medical Devices segment.

Cost of sales for the Prescription Medicine segment for the three months ended September 30, 2024, consisted of an 11% benefit in third-party product cost of sales, 88% royalty expenses, and 23% 3PL order fulfillment and shipping expenses.

Cost of sales for the Medical Device segment for the three months ended September 30, 2024, consisted of 80% raw materials and 20% production labor.

Cost of sales decreased by $121,470 or 30% during the three months ended September 30, 2024, compared to the same period in 2023. For the three months ended September 30, 2024, and September 30, 2023, cost of sales as a percentage of net sales was 18% and 24%, respectively. The decrease in cost of sales as a percentage of net sales was primarily the result of fully reserved inventory being sold through during the three months ended September 30, 2024, compared to the same period in 2023.

Gross Profit

Gross profit for the three months ended September 30, 2024, was $1,289,361 or 82%, composed of $809,356 of gross profit from Prescription Medicines and $480,005 from Medical Devices. Gross profit for the three months ended September 30, 2023, was $1,266,182, or 76% of net sales, composed of $840,371 of gross profit from Prescription Medicines and $425,811 from Medical Devices. The increase in gross profit was driven by the factors noted above.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses for the three months ended September 30, 2024, were $2,301,305, composed of $471,669 of selling, general and administrative expenses of our Prescription Medicines segment, $600,565 of selling, general and administrative expenses of our Medical Devices segment and $1,229,071 of general corporate expenses.

Selling, general and administrative expenses for the three months ended September 30, 2023, were $2,001,935, composed of $251,674 of selling, general and administrative expenses of our Prescription Medicines segment, $493,447 of selling, general and administrative expenses of our Medical Devices segment and $1,256,814 of general corporate expenses.

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Selling, general and administrative expenses increased by $299,370 or 15% during the three months ended September 30, 2024, compared to the same period in 2023. Increased selling general and administrative expenses were primarily driven by a waiver of FY 23 PDUFA fees by the FDA resulting in a $312,551 increase in PDUFA expense and increased franchise taxes of $121,205 and increased other operating expenses of $5,774 partially offset by decreased insurance expenses of $57,096, decreased professional service fees of $52,224 and decreased stock-based compensation expense of $30,840.

Warrant issuance costs

For the three months ended September 30, 2024, and September 30, 2023, respectively, the Company recorded warrant issuance costs of $0 and $2.9 million associated with the Private Placement.

Research and development

Research and development expenses for the three months ended September 30, 2024, were $588,355, composed of $588,355 for our Prescription Medicines segment and $0 for our Medical Devices segment, respectively.

Research and development expenses for the three months ended September 30, 2023, were $389,093, composed of $369,505 for our Prescription Medicines segment and $19,588 for our Medical Devices segment, respectively.

Research and development expenses for the Prescription Medicines segment for the three months ended September 30, 2024, are composed of $463,527 for clinical development, $119,265 for consulting fees, and $5,563 for legal fees related to the Company’s OTC Strategies related to Stendra®. Research and development expenses for the Prescription Medicines segment for the three months ended September 30, 2023, are composed of $187,911 for clinical development and $181,594 for consulting fees related to the Company’s OTC Strategies related to Stendra®.

Research and development expenses for the Medical Devices segment for the three months ended September 30, 2024, were $0. Research and development expenses for the Medical Devices segment for the three months ended September 30, 2023, are composed of $19,588 for license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies.

Research and development expenses increased by $199,262 or 51% during the three months ended September 30, 2024, compared to the same period in 2023. Increased research and development expenses were primarily driven by increased clinical development expenses and consulting fees related to the Company’s OTC strategies related to Stendra®.

Depreciation and amortization

Depreciation and amortization expenses for the three months ended September 30, 2024, were $739,449, composed of $521,597 of depreciation and amortization expenses of our Prescription Medicines segment and $217,852 of depreciation and amortization expenses of our Medical Devices segment.

Depreciation and amortization expenses for the three months ended September 30, 2023, were $826,795, composed of $575,470 of depreciation and amortization expenses of our Prescription Medicines segment and $251,325 of depreciation and amortization expenses of our Medical Devices segment.

Change in fair value of derivative liability

For the three months ended September 30, 2024, the Company recorded a gain of $0.2 million for the change in fair value of the derivative liability compared to a loss of $0.4 million for the three months ended September 30, 2023. The gains and losses related to the change in the fair value of a derivative liability established for certain bifurcated features of the Series A Preferred Stock issued in the Private Placement (as defined herein).

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Change in fair value of warrant liability

For the three months ended September 30, 2024, and September 30, 2023, respectively, the Company recorded a gain of $0 and $11.7 million for the change in fair value of the warrant liability. The gain related to the decrease in the fair value of warrants issued in the Private Placement (as defined herein) which were classified as liabilities in accordance with ASC 815.

Interest Income

Interest income for the three months ended September 30, 2024, and 2023, was $75,817 and $168,481, respectively. Petros invested its cash in money market securities during 2024 and 2023.

Interest Expense, Promissory Note

In January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 in connection with the Vivus Settlement Agreement. Interest expense, promissory note for the three months ended September 30, 2024, and 2023, was $158,730 and $131,351, respectively.

Loss on issuance of Series A Preferred Stock

As the fair value of the liabilities required to be subsequently measured at fair value exceeded the net proceeds received, for three months ended September 30, 2023, the Company recognized the excess of the fair value over the net proceeds received as a loss upon issuance of preferred stock of $11.1 million, which is included in other income (expense) in the condensed consolidated statement of operations. No similar losses were recognized during the three months ended September 30, 2024, as no such issuances of this nature occurred.

Liquidity and Capital Resources

General

Cash totaled $3,894,685 at September 30, 2024, compared to $13,336,975 at December 31, 2023.

The Company has experienced net losses and negative cash flows from operations since inception. As of September 30, 2024, we had cash of $3.9 million, negative working capital of $1.8 million, and an accumulated deficit of $103.9 million. The Company’s plans include, or may include, utilizing cash on hand, as well as exploring additional ways to raise capital in addition to increasing cash flows from operations. In January 2022, the Company executed a promissory note in favor of Vivus in connection with the Vivus Settlement Agreement in the principal amount of $10,201,758, net of a prepayment of $900,000. The terms of this promissory note are discussed in the section titled “Vivus Settlement Agreement, Promissory Note and the Security Agreement” above.

To date, the Company’s principal sources of capital used to fund operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities. The Company does not currently have sufficient available liquidity to fund its operations for at least the next 12 months. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these interim unaudited condensed consolidated financial statements are issued.

July 2023 Private Placement

On July 13, 2023, the Company entered into the Purchase Agreement with certain accredited investors (the “Investors”), pursuant to which the Company agreed to sell in a private placement to the Investors (i) an aggregate of 15,000 shares of the Company’s newly-designated Series A Preferred Stock initially convertible into up to 6,666,668 shares of the Company’s common stock at an initial conversion price of $2.25 per share and (ii) warrants to acquire up to an aggregate of 6,666,668 shares of common stock (the “Warrants”) at an initial exercise price of $2.25 per share (collectively, the “Private Placement”). Pursuant to the terms of the Certificate of Designations and the Warrants, each of the Conversion Price (as defined below) and the exercise price and the number of shares underlying the Warrants is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of common stock, or securities convertible, exercisable or exchangeable for common stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). As of September 30, 2024, the Conversion Price and the exercise price of the Warrants was equal to $2.25 per share.

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Series A Preferred Stock

The terms of the Series A Preferred Stock are as set forth in the form of Certificate of Designations. The Series A Preferred Stock is convertible into shares of common stock (the “Conversion Shares”) at the election of the holder at any time at an initial conversion price of $2.25 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of common stock, or securities convertible, exercisable or exchangeable for common stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). The Company is required to redeem the Series A Preferred Stock in 13 equal monthly installments, commencing on November 1, 2023. The amortization payments due upon such redemptions are payable, at the Company’s election, in cash at 107% of the Installment Redemption Amount (as defined in the Certificate of Designations), or subject to certain limitations, in shares of common stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the three lowest closing prices of the common stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) $0.396 or such lower amount as permitted, from time to time, by the Nasdaq Stock Market, subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations or other similar events. The Company may require holders to convert their Series A Preferred Stock into Conversion Shares if the closing price of the Common stock exceeds $6.75 per share (subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations or other similar events) for 20 consecutive trading days and the daily dollar trading volume of the common stock exceeds two million dollars ($2,000,000) per day during the same period and certain equity conditions described in the Certificate of Designations are satisfied.

The holders of the Series A Preferred Stock are entitled to dividends of 8% per annum, compounded monthly, which are payable at the Company’s option, in cash or shares of common stock, or in combination thereof, in accordance with the terms of the Certificate of Designations. On September 29, 2023, the Company filed an amendment to the Certificate of Designations with the Secretary of State of the State of Delaware, pursuant to which the terms of the Series A Preferred Stock were amended to permit certain additional procedures for the payment of redemptions and conversions Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series A Preferred Stock will accrue dividends at the rate of 15% per annum.

On October 11, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing a Certificate of Amendment to the Certificate of Designations with the Secretary of State (the “October 2024 Certificate of Amendment”). The October 2024 Certificate of Amendment amends the Certificate of Designations to, among other things, provide that, except as required by applicable law, the holders of the Series A Preferred Stock will be entitled to vote with holders of the common stock on an as converted basis, with the number of votes to which each holder of Series A Preferred Stock is entitled to be determined by dividing the Stated Value by a conversion price equal to $2.25 per share, which was the “Minimum Price” (as defined in Nasdaq Listing Rule 5635(d)) applicable immediately before the execution and delivery of the Purchase Agreement, subject to certain beneficial ownership limitations and adjustments for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions, as set forth in the Certificate of Designations. The October 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of October 11, 2024.

During the nine months ended September 30, 2024, the Company has redeemed or converted approximately 8,983 shares of Series A Preferred Stock and issued 6,563,523 shares of common stock pursuant to the terms of the Certificate of Designations.

There is no established public trading market for the Series A Preferred Stock and the Company does not intend to list the Series A Preferred Stock on any national securities exchange or nationally recognized trading system.

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Warrants

The Warrants became exercisable for shares of common stock (the “Warrant Shares”) immediately upon issuance, at an initial exercise price of $2.25 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of common stock, or securities convertible, exercisable or exchangeable for common stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). Upon any such price-based adjustment, the number of Warrant Shares issuable upon exercise of the Warrants will be increased proportionately. There is no established public trading market for the Warrants and the Company does not intend to list the Warrants on any national securities exchange or nationally recognized trading system.

On March 21, 2024, the Company entered into a Waiver and Amendment with the Investors in the Private Placement, effective as of December 31, 2023. The Waiver and Amendment amended certain terms of the Warrants relating to the rights of the holders of the Warrants to provide that, in the event of a Fundamental Transaction (as defined in the Warrants) that is not within the Company’s control, including not approved by the Company’s Board of Directors, the holder of a Warrant shall only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of such Warrant, that is being offered and paid to the holders of the Company’s common stock in connection with the Fundamental Transaction.

Debt

Vivus Note

As noted above, in January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 in connection with the Vivus Settlement Agreement. For more information, see the section above titled “—Vivus Settlement Agreement, Promissory Note and the Security Agreement.”

Cash Flows

The following table summarizes the Company’s cash flows for the nine months ended September 30, 2024, and 2023:


	For the Nine Months Ended September 30,
	2024		2023
Net cash used in operating activities	$	(3,568,456)	$	(5,366,635)
Net cash used in investing activities		(19,138)		—
Net cash provided by (used in) financing activities		(5,854,696)		13,910,320
Net increase (decrease) in cash	$	(9,442,290)	$	8,543,685

Cash Flows from Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2024, was $3,568,456, which primarily reflected the Company’s net loss of $5,045,350, in addition to noncash adjustments to reconcile net loss to net cash used in operating activities of $824,807 consisting primarily of depreciation and amortization and change in the fair value of derivative liability, the Company also had changes in operating assets and liabilities of $2,301,701 largely driven by accrued product returns provision and API.

Net cash used in operating activities for the nine months ended September 30, 2023, was $5,366,635 which primarily reflected our net loss of $8,481,338, in addition to noncash adjustments to reconcile net loss to net cash used in operating activities of $4,231,207 consisting primarily of depreciation and amortization, costs associated with the Private Placement, and changes in operating assets and liabilities of $1,116,504.

Cash Flows from Investing Activities

Net cash used in investing activities was $19,138 for the nine months ended September 30, 2024, consisting of $19,138 for the purchase of office equipment for use in the Medical Device segment.

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Cash Flows from Financing Activities

Net cash used in financing activities was $5,854,696 for the nine months ended September 30, 2024, consisting of $5,089,417 of redemptions of Series A Preferred Stock and $765,279 of principal payments of the promissory note.

Net cash provided by financing activities was $13,910,320 for the nine months ended September 30, 2023, consisted of the gross proceeds of the Private Placement, offset by payments of the promissory note.

Off-Balance Sheet Commitments and Arrangements

The Company has not entered into any off-balance sheet financial guarantees or other off-balance sheet commitments to guarantee the payment obligations of any third parties. The Company has not entered into any derivative contracts that are indexed to the Company’s shares and classified as stockholder’s equity or that are not reflected in the Company’s financial statements included in this Quarterly Report on Form 10-Q. Furthermore, the Company does not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity or market risk support to such entity. The Company does not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us.

Contingencies

Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management, in consultation with its legal counsel as appropriate, assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company, in consultation with legal counsel, evaluates the perceived merits of any legal proceedings or unasserted claims, as well as the perceived merits of the amount of relief sought or expected to be sought therein. If the assessment of a contingency indicates it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s financial statements. If the assessment indicates a potentially material loss contingency is not probable, but is reasonably possible, or is probable, but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss, if determinable and material, would be disclosed. Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed.

Reconciliation of Non-GAAP Financial Measures

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure utilized by management to evaluate the Company’s performance on a comparable basis. The Company believes that Adjusted EBITDA is useful to investors as a supplemental way to evaluate the ongoing operations of the Company’s business as Adjusted EBITDA may enhance investors’ ability to compare historical periods as it adjusts for the impact of financing methods, tax law and strategy changes, and depreciation and amortization and to evaluate the Company’s ability to service debt. In addition, Adjusted EBITDA is a financial measurement that management and the Company’s Board of Directors use in their financial and operational decision-making and in the determination of certain compensation programs. Adjusted EBITDA is a non-GAAP financial measure commonly used in the Company’s industry and should not be construed as an alternative to net income as an indicator of operating performance (as determined in accordance with GAAP). The Company’s presentation of Adjusted EBITDA may not be comparable to similarly titled measures reported by other companies.

Adjusted EBITDA is adjusted to exclude certain items that affect comparability. The adjustments are itemized in the tables below. You are encouraged to evaluate these adjustments and the reason the Company considers them appropriate for supplemental analysis. In evaluating adjustments, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments set forth below. The presentation of these adjustments should not be construed as an inference that future results will be unaffected by unusual or recurring items.

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The Company defines Adjusted EBITDA as net income (loss) adjusted to exclude (i) interest expense, net, (ii) depreciation and amortization and (iii) income taxes, as further adjusted to eliminate the impact of certain items that the Company does not consider indicative of its ongoing operating performance or that are non-recurring in nature. For example, Adjusted EBITDA:

●

does not reflect the Company’s capital expenditures, future requirements for capital expenditures or contractual commitments;

●

does not reflect changes in, or cash requirements for, the Company’s working capital needs;

●

does not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on the Company’s debt; and

●

does not reflect payments related to income taxes, if applicable.

The following table presents a reconciliation of net income (loss) to Adjusted EBITDA for the three and nine months ended September 30, 2024, and 2023:


	For the Nine Months Ended				For the Three Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Net Loss	$	(5,045,350)	$	(8,481,338)	$	(2,220,661)	$	(4,549,508)
Interest income		(347,028)		(287,722)		(75,817)		(168,481)
Interest expense, promissory note		393,450		410,317		158,730		131,351
Depreciation and amortization expense		2,175,126		2,480,385		739,449		826,795
EBITDA		(2,823,802)		(5,878,358)		(1,398,299)		(3,759,843)
Stock based compensation		197,215		204,492		—		30,840
Change in fair value of derivative liability		(3,550,000)		430,000		(202,000)		430,000
Change in fair value of warrant liability		—		(11,739,000)		—		(11,739,000)
Loss on issuance of Series A Preferred Stock		—		11,088,997		—		11,088,997
Adjusted EBITDA	$	(6,176,587)	$	(5,893,869)	$	(1,600,299)	$	(3,949,006)

Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of the Company’s results as reported under GAAP.

Gross Billings

Gross billings is a non-GAAP financial measure utilized as a key performance metric by management and the Company’s Board of Directors in their financial and operational decision-making as well as for the preparation of the annual budget. The Company believes that gross billings is useful to investors as a supplemental way to provide an alternative measure of the total demand for the products sold by the Company. Gross billings is a non-GAAP financial measure commonly used in the Company’s industry and should not be construed as an alternative to net sales as an indicator of operating performance (as determined in accordance with GAAP). The Company’s presentation of gross billings may not be comparable to similarly titled measures reported by other companies.

Gross billings is adjusted to exclude certain items that affect comparability. The adjustments are itemized in the tables below. You are encouraged to evaluate these adjustments and the reason the Company considers them appropriate for supplemental analysis. In evaluating adjustments, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments set forth below. The presentation of these adjustments should not be construed as an inference that future results will be unaffected by unusual or recurring items.

The Company defines gross billings as the amount of its aggregate sales billed to customers at standard prices before the application of certain adjustments that reduce the net amount received from customers, including product returns, certain rebates and coupon redemptions, discounts and fees.

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The following table presents a reconciliation of net sales to gross billings for the three and nine months ended September 30, 2024, and 2023:


	For the Three Months Ended				For the Nine Months Ended
	September 30				September 30
	2024		2023		2024		2023
Net Sales	$	1,576,366	$	1,674,657	$	4,386,640	$	6,186,638
Product Returns		354,759		516,440		1,157,728		1,290,465
Contract Rebates		232,956		225,085		707,957		1,037,271
Chargebacks		58,300		42,190		168,419		118,490
Cash Discounts		35,445		36,266		101,940		125,679
Distribution Service Fees		231,677		216,234		803,249		678,857
Coupon Redemptions		105,982		146,626		337,982		1,176,562
Gross Billings	$	2,595,485	$	2,857,498	$	7,663,915	$	10,613,962

Gross billings has limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of the Company’s results as reported under GAAP.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

ITEM 4. CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”)) as of the period covered by this report. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective to ensure that information required to be disclosed in reports filed by us under the Exchange Act is recorded, processed, summarized and reported within the required time periods and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

A material weakness is a control deficiency (within the meaning of Public Company Accounting Oversight Board (PCAOB) Auditing Standard No. 5) or combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. As disclosed in Part II Item 9A Controls and Procedures in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, we identified a material weaknesses in internal control related to (1) Petros has an insufficient level of monitoring and oversight controls and does not enforce the implementation of key controls reflected on its internal control process matrices; (2) the sizes of Petros’ accounting and IT departments make it impracticable to achieve an appropriate segregation of duties; and (3) Petros does not have appropriate IT access related controls.

Management plans to expand the scope of its remediation of its internal controls over financial reporting at the consolidated level and has developed a plan to address the remediation of the foregoing deficiencies. Petros’ remediation efforts are ongoing and it will continue its initiatives to implement and document policies, procedures, and internal controls. The remediation efforts include the implementation of additional controls to ensure all risks have been addressed. Management is further emphasizing compliance with existing internal controls. The Company has continued to utilize an external consultant to assist in the remediation of the deficiencies.

Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and

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instances of fraud, if any, have been detected. Management believes that the financial statements included in this Quarterly Report on Form 10-Q fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting other than as noted above.

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PART II—OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of business.

The information set forth in Note 14 Commitments and Contingencies of the Notes to Consolidated Financial Statements of this Quarterly Report on Form 10-Q is incorporated by reference herein.

ITEM 1A. RISK FACTORS.

The following description of risk factors includes any material changes to, and supersedes the description of, risk factors associated with our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors” of our 2023 Form 10-K. Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in our annual report, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results, and stock price.

The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Quarterly Report on Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Quarterly Report on Form 10-Q.

We defaulted on certain covenants included in the Note with Vivus that could result in the acceleration of the related debt or the exercise of other remedies.

On October 1, 2024, we failed to make the payment due pursuant to the Note and related Security Agreement in the amount of $0.5 million, constituting an event of Default (as defined in the Note) under the Note and Security Agreement. The outstanding principal amount on the Note, plus accrued and unpaid interest thereon, was $7.2 million as of September 30, 2024.

Borrowings under the Note and Security Agreement are secured by the Company’s Stendra® API and products and the Company’s rights under the License Agreement (the “Collateral”). Pursuant to the Note, upon and at all times after the occurrence of any Event of Default, all principal outstanding under the Note will bear increased interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note is paid (regardless of whether any default is waived or cured). Further, Vivus, at its option, may declare any or all amounts owing under the Note (whether principal, interest, or otherwise), to be due and payable, and, subject to the terms of the Security Agreement, foreclose on the Collateral. If the Note is placed in the hands of any attorney for collection, or if it is collected through any legal proceeding at law or in equity or in bankruptcy, receivership, or other court proceedings, the Company will also be required to pay all costs of collection including, but not limited to, court costs and attorneys’ fees. Any such actions could further impair our ability to operate our business and may result in the loss of key assets necessary for our operations. If we are unable to cure the default, obtain a waiver, or restructure the terms of the Note, we may be forced to seek additional financing on unfavorable terms, restructure our operations, or pursue other alternatives, including bankruptcy.

If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy Nasdaq’s continued listing requirements, including, among other things, a minimum closing bid price of $1.00 per share or risk delisting, which would have a material adverse effect on our business. A delisting of our common stock from The Nasdaq Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

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On May 15, 2024, we received notice from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the 30 consecutive business day period between April 3, 2024, through May 14, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). The letter also indicated that we were provided with a compliance period until November 11, 2024in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency Nasdaq will provide notice that the Company’s common stock will be subject to delisting. There can be no assurance that the Nasdaq staff would grant the Company’s request for continued listing subsequent to any delisting notification. In the event of such a notification, the Company may appeal the Nasdaq staff’s determination to delist its securities.

There is no assurance that we will maintain compliance with such minimum listing requirements. If our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

On August 13, 2024, the Company issued 136,986 shares of common stock to Maxim Group LLC (“Maxim”) in connection with a services agreement with Maxim. The Company relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder for transactions not involving a public offering.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION.

On September 16, 2024, the Board of Directors of the Company determined that the Company’s 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”) will be held on Wednesday, November 20, 2024, and that the record date for the determination of stockholders of the Company entitled to receive notice of and to vote at the 2024 Annual Meeting shall be the close of business on October 14, 2024. The time and location of the 2024 Annual Meeting will be as set forth in the Company’s definitive proxy statement for the 2024 Annual Meeting to be filed with the Securities and Exchange Commission.

Due to the fact that the date of the 2024 Annual Meeting has been changed by more than 30 days from the anniversary date of the 2023 Annual Meeting of Stockholders, the Company is providing the due date for submission of any qualified stockholder proposal or qualified stockholder nominations.

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Stockholders of the Company who wish to have a proposal considered for inclusion in the Company’s proxy materials for the 2024 Annual Meeting pursuant to Rule 14a-8 under the Exchange Act, must ensure that such proposal is received by the Company’s President and Chief Commercial Officer, Fady Boctor, at 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036, on or before the close of business on September 29, 2024, which the Company has determined to be a reasonable time before it expects to begin in print and send its proxy materials in accordance with Rule 14a-5(f) and Rule 14a-8(e) under the Exchange Act. Any such proposal must also meet the requirements set forth in the rules and regulations of the Securities and Exchange Commission in order to be eligible for inclusion in the proxy materials for the 2024 Annual Meeting.

In addition, in accordance with the requirements contained in the Company’s amended and restated By-laws (“By-laws”), stockholders of the Company who wish to bring business before the 2024 Annual Meeting outside of Rule 14a-8 of the Exchange Act or to nominate a person for election as a director must ensure that written notice of such proposal (including all information specified in the Company’s By-laws) is received by the Company’s President and Chief Commercial Officer at the address specified above no later than the close of business on September 29, 2024. Any such proposal must meet the requirements set forth in the Company’s By-laws in order to be brought before the 2024 Annual Meeting.

In addition, to comply with the universal proxy rules, stockholders who intend to solicit proxies in support of director nominees other than our nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act by September 29, 2024.

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ITEM 6. EXHIBITS.

Exhibit No.		Description
3.1		Certificate of Amendment to the Certificate of Designations of Series A Convertible Preferred Stock of Petros Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 17, 2024).
3.2*		Certificate of Amendment to the Certificate of Designations of Series A Convertible Preferred Stock of Petros Pharmaceuticals, Inc.
10.1*		Form of Amendment Agreement, dated November 13, 2024, by and between Petros Pharmaceuticals, Inc. and the investors party thereto.
10.2+		Offer Letter Amendment, effective as of October 16, 2024, by and between the Company and Fady Boctor (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 18, 2024).
10.3		Form of Amendment Agreement, dated October 11, 2024, by and between Petros Pharmaceuticals, Inc. and the investors party thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 17, 2024).
31.1*		Rule 13a-14(a)/15d-14(a) Certification – Principal Executive Officer.
31.2*		Rule 13a-14(a)/15d-14(a) Certification – Principal Financial Officer.
32**		Section 1350 Certification – Principal Executive Officer and Principal Financial Officer.
101		The following materials from Petros Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations; (iii) Consolidated Changes in Stockholders’ Equity/Members’ Capital; (iv) Consolidated Statements of Cash Flows; and (v) Notes to the Consolidated Financial Statements.
104		Cover Page Interactive Data File, formatted in iXBRL and contained in Exhibit 101.

*	Filed herewith.

**	Furnished herewith.

+	Management contract or compensatory plan or arrangement.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Petros Pharmaceuticals, Inc.

Date: November 13, 2024	By:	/s/ Fady Boctor
		Fady Boctor
		Chief Commercial Officer and Principal Executive Officer

Date: November 13, 2024	By:	/s/ Mitchell Arnold
		Mitchell Arnold
		Vice President of Finance and Principal Financial Officer

Exhibit 3.2

CERTIFICATE OF AMENDMENT

CERTIFICATE OF DESIGNATIONS

SERIES A CONVERTIBLE PREFERRED STOCK

PETROS PHARMACEUTICALS, INC.

PURSUANT TO SECTION 242 OF THE

DELAWARE GENERAL CORPORATION LAW

This Certificate of Amendment to the Certificate of Designations of Series A Convertible Preferred Stock (the “Amendment”) is dated as of November 13, 2024.

WHEREAS, the board of directors (the “Board”) of Petros Pharmaceuticals, Inc., a Delaware corporation (the “Company”), pursuant to the authority granted to it by the Company’s Amended and Restated Certificate of Incorporation (as amended, the “Certificate of Incorporation”) and Section 151(g) of the Delaware General Corporation Law (the “DGCL”), has previously fixed the rights, preferences, restrictions and other matters relating to a series of the Company’s preferred stock, consisting of 15,000 authorized shares of preferred stock, classified as Series A Convertible Preferred Stock (the “Preferred Stock”), and the Certificate of Designations of the Preferred Stock (as amended, the “Certificate of Designations”) was initially filed with the Secretary of State of the State of Delaware on July 14, 2023 evidencing such terms;

WHEREAS, pursuant to Section 32(b) of the Certificate of Designations, the Certificate of Designations or any provision thereof may be amended by obtaining the affirmative vote at a meeting duly called for such purpose, or written consent without a meeting in accordance with the DGCL, of the holders of at least a majority of the outstanding shares of Preferred Stock (the “Required Holders”), voting separately as a single class, and with such other stockholder approval, if any, as may then be required pursuant to the DGCL and the Certificate of Incorporation;

WHEREAS, the Required Holders pursuant to the Certificate of Designations have consented, in accordance with the DGCL, on November 13, 2024, to this Amendment on the terms set forth herein; and

WHEREAS, the Board has duly adopted resolutions proposing to adopt this Amendment and declaring this Amendment to be advisable and in the best interest of the Company and its stockholders.

NOW, THEREFORE, this Amendment has been duly adopted in accordance with Section 242 of the DGCL and has been executed by a duly authorized officer of the Company as of the date first set forth above to amend the terms of the Certificate of Designations as follows:

1.	Section 15 of the Certificate of Designations is hereby amended to include a new Section 15(q) as follows:

(q)Cash Minimum. From November 13, 2024 until January 15, 2025, the Company shall, at all times, maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $1,500,000. Such cash shall be maintained in one or more domestic deposit accounts, money market accounts or certificates of deposit (with a maturity of no more than three months) with one or more Eligible Banks. For purposes hereof, an “Eligible Bank” is a U.S. chartered commercial bank with total assets in excess of $300 billion.

2.	Section 33(nn) of the Certificate of Designations is hereby amended and restated to read as follows:

(nn)

“Installment Date” means (i) the earlier of (x) the first Trading Day of the calendar month which is at least 25 Trading Days after the date that the initial Registration Statement is declared effective by the SEC

and (y) November 1, 2023, (ii) thereafter, the first Trading Day of the calendar month immediately following the previous Installment Date until November 1, 2024, and (iii) the Maturity Date.

3.	Section 33(tt) of the Certificate of Designations is hereby amended and restated to read as follows:

(tt) “Maturity Date” shall mean January 15, 2025; provided, however, the Maturity Date may be extended at the option of a Holder (i) in the event that, and for so long as, a Triggering Event shall have occurred and be continuing or any event shall have occurred and be continuing that with the passage of time and the failure to cure would result in a Triggering Event or (ii) through the date that is twenty (20) Business Days after the consummation of a Fundamental Transaction in the event that a Fundamental Transaction is publicly announced or a Change of Control Notice is delivered prior to the Maturity Date, provided further that if a Holder elects to convert some or all of its Preferred Shares pursuant to Section 4 hereof, and the Conversion Amount would be limited pursuant to Section 4(d) hereunder, the Maturity Date shall automatically be extended until such time as such provision shall not limit the conversion of such Preferred Shares.

[Signature Page Follows]

IN WITNESS WHEREOF, the Company has caused this Amendment to be signed by its duly authorized officer this 13^thday of November, 2024.

PETROS PHARMACEUTICALS, INC.

By:	/s/ Joshua Silverman
Name:	Joshua Silverman
Title:	Chairman of the Board

Exhibit 10.1

AMENDMENT AGREEMENT

This Amendment Agreement (this “Agreement”), dated as of November 13, 2024, is by and between Petros Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and each investor listed on the signature pages attached hereto (each an “Investor,” and collectively, the “Investors”).

WITNESSETH

WHEREAS, the Company and the Investors are party to that certain Securities Purchase Agreement, dated as of July 13, 2023 (the “Purchase Agreement”), pursuant to which the Company issued to the Investors shares of the Company’s Series A Convertible Preferred Stock, par value $0.0001 per share (the “Preferred Stock”), the terms of which are set forth in the Certificate of Designations of the Preferred Stock (the “Certificate of Designations”), and warrants (the “Warrants,” and, together with the Purchase Agreement and the Certificate of Designations, the “Transaction Documents”) to purchase shares of the Company’s common stock, par value $0.0001 per share; and

WHEREAS, the undersigned collectively hold at least a majority of the outstanding shares of Preferred Stock and thereby constitute the Required Holders.

NOW, THEREFORE, in consideration of the premises and mutual covenants and obligations hereinafter set forth, the parties hereto, intending legally to be bound, hereby agree as follows:

Definitions. Capitalized terms used herein but not otherwise defined herein shall have the respective meanings given such terms in the Certificate of Designations.

Agreement to Defer. The Investors, on behalf of all Holders, hereby agree that payment by the Company of any payment amounts that have accrued and are unpaid as of the date hereof pursuant to the Certificate of Designations (the “Amounts”), shall be deferred until January 15, 2025, as to all Holders. In addition, the Investors, on behalf of all Holders, hereby waive any breach or violation of the Transaction Documents resulting from the Company’s failure to timely deliver the Amounts and further agree that such failure to pay shall not otherwise trigger any right or remedy of the Investors.

Amendment to the Certificate of Designations. The parties hereto hereby agree to amend the terms of the Preferred Stock as set forth in the Certificate of Designations of the Preferred Stock in the form attached hereto as Exhibit A (the “Amendment”). Upon the effectiveness of this Agreement, the Company shall promptly file the Amendment with the Secretary of State of the State of Delaware and provide a copy thereof to each Investor promptly after such filing.

Counterparts; Facsimile Execution. This Agreement may be executed in one or more counterparts (including by electronic mail, in PDF or by DocuSign or similar electronic signature), all of which shall be considered one and the same agreement and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other parties. Counterparts may be delivered via facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000,

Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

No Consideration. No Investor has received any consideration for its entry into this Agreement which has not also been given to each other Investor. There are no side letters or other agreements between the Company and another Investor related to the execution and delivery of this Amendment or the matters contemplated hereby. Any contravention of the foregoing representations shall be immediately disclosed to each Investor and each Investor shall be entitled, at its option, to receive the benefits of such consideration, side letter or other agreement.

Governing Law. THIS AGREEMENT SHALL BE SUBJECT TO THE PROVISIONS REGARDING GOVERNING LAW SET FORTH IN SECTION 9(A) OF THE PURCHASE AGREEMENT, AND SUCH PROVISIONS ARE INCORPORATED HEREIN BY THIS REFERENCE, MUTATIS MUTANDIS.

Terms and Conditions of the Transaction Documents. Except as modified and amended herein, all of the terms and conditions of the Transaction Documents shall remain in full force and effect.

[Signature pages follow immediately.]

[Company Signature Page to Amendment Agreement]

IN WITNESS WHEREOF, the undersigned has executed and delivered this Agreement as of the date first above written.

	Company:

	PETROS PHARMACEUTICALS, INC.


	By:
	Name:	Joshua Silverman
	Title:	Chairman of the Board

[Investor Signature Page to Amendment Agreement]

IN WITNESS WHEREOF, the undersigned has executed and delivered this Agreement as of the date first above written.

	Name of Investor:



	By:
	Name of signatory:
	Title:

Exhibit A

Form of Amendment to Certificate of Designations

Exhibit 31.1

CERTIFICATION PURSUANT TO SARBANES–OXLEY ACT OF 2002

I, Fady Boctor, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Petros Pharmaceuticals, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: November 13, 2024	By:	/s/ Fady Boctor
		Fady Boctor
		Chief Commercial Officer and Principal Executive Officer

Exhibit 31.2

CERTIFICATION PURSUANT TO SARBANES–OXLEY ACT OF 2002

I, Mitchell Arnold, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Petros Pharmaceuticals, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(a)

(b)

(c)

(d)

5.	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

3
Date: November 13, 2024	By:	/s/ Mitchell Arnold
		Mitchell Arnold
		Vice President of Finance and Principal Financial Officer

Exhibit 32

CERTIFICATION PURSUANT TO SECTION 906

OF THE SARBANES–OXLEY ACT OF 2002

In connection with the Quarterly Report of Petros Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the dates indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

1.	the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2.	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

3
	Petros Pharmaceuticals, Inc.

Date: November 13, 2024	By:	/s/ Fady Boctor
		Fady Boctor
		Chief Commercial Officer and Principal Executive Officer

Date: November 13, 2024	By:	/s/ Mitchell Arnold
		Mitchell Arnold
		Vice President of Finance and Principal Financial Officer

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 12, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-39752
Entity Registrant Name	Petros Pharmaceuticals, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-1410058
Entity Address, Address Line One	1185 Avenue of the Americas
Entity Address, Address Line Two	3rd Floor
Entity Address, City or Town	New York
Entity Address State Or Province	NY
Entity Address, Postal Zip Code	10036
City Area Code	973
Local Phone Number	242-0005
Title of 12(b) Security	Common stock
Trading Symbol	PTPI
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		10,014,872
Entity Central Index Key	0001815903
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash	$ 3,894,685	$ 13,336,975
Accounts receivable, net	1,948,613	2,226,151
Inventories	1,405,651	1,610,391
Prepaid inventory	1,649,212	1,182,899
Prepaid expenses and other current assets	1,826,319	2,033,980
Total current assets	10,724,480	20,390,396
Fixed assets, net	18,819	28,957
Intangible assets, net	6,825,887	8,971,737
API purchase commitment	2,999,514	4,178,446
Right of use assets	124,930	226,259
Total assets	20,693,630	33,795,795
Current liabilities:
Current portion of promissory note	2,326,050	1,156,550
Accounts payable	1,600,992	1,713,253
Accrued expenses	6,539,371	5,360,077
Accrued Series A Convertible Preferred payments payable	1,742,918	2,047,583
Other current liabilities	352,773	493,288
Total current liabilities	12,562,104	10,770,751
Promissory note, net of current portion	4,922,585	6,857,364
Derivative Liability		3,550,000
Other long-term liabilities	91,832	137,657
Total liabilities	17,576,521	21,315,772
Commitments and contingencies (see note 14)
Series A convertible redeemable preferred stock (par value $0.0001 per share and $1,000 stated value), 15,000 and 15,000 shares authorized at September 30, 2024, and December 31, 2023, respectively; 1,039 and 10,022 shares issued and outstanding at September 30, 2024, and December 31, 2023, respectively; Liquidation preference of $1,260,385 and $11,271,365, as of September 30, 2024, and December 31, 2023, respectively.	1,398	408,982
Stockholders' Equity:
Common stock (par value $0.0001 per share, 250,000,000 and 250,000,000 shares authorized at September 30, 2024, and December 31, 2023, respectively; 10,014,872 and 2,991,377 shares issued and outstanding as of September 30, 2024, and December 31, 2023, respectively)	1,002	298
Additional paid-in capital	107,049,640	110,960,324
Accumulated deficit	(103,934,931)	(98,889,581)
Total Stockholders' Equity	3,115,711	12,071,041
Total Liabilities, Convertible Redeemable Preferred Stock and Stockholders' Equity	$ 20,693,630	$ 33,795,795

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
CONDENSED CONSOLIDATED BALANCE SHEETS
Redeemable convertible preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, stated value	$ 1,000	$ 1,000
Redeemable convertible preferred stock, authorized (in shares)	15,000	15,000
Redeemable convertible preferred stock, issued (in shares)	1,039	10,022
Redeemable convertible preferred stock, outstanding (in shares)	1,039	10,022
Redeemable convertible preferred stock, Liquidation preference	$ 1,260,385	$ 11,271,365
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	250,000,000	250,000,000
Common stock, shares issued	10,014,872	2,991,377
Common stock, shares outstanding	10,014,872	2,991,377

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Net sales	$ 1,576,366	$ 1,674,657	$ 4,386,640	$ 6,186,638
Cost of goods sold	287,005	408,475	947,946	1,473,073
Gross profit	1,289,361	1,266,182	3,438,694	4,713,565
Operating expenses:
Selling, general and administrative	2,301,305	2,001,935	7,299,391	6,382,166
Warrant issuance costs		2,855,000		2,855,000
Research and development expense	588,355	389,093	2,513,105	1,574,760
Depreciation and amortization expense	739,449	826,795	2,175,126	2,480,385
Total operating expenses	3,629,109	6,072,823	11,987,622	13,292,311
Loss from operations	(2,339,748)	(4,806,641)	(8,548,928)	(8,578,746)
Other income (expenses):
Change in fair value of derivative liability	202,000	(430,000)	3,550,000	(430,000)
Change in fair value of warrant liability		11,739,000		11,739,000
Interest income	75,817	168,481	347,028	287,722
Interest expense, promissory note	(158,730)	(131,351)	(393,450)	(410,317)
Loss on issuance of Series A Preferred Stock		(11,088,997)		(11,088,997)
Total other income	119,087	257,133	3,503,578	97,408
Net loss before income taxes	(2,220,661)	(4,549,508)	(5,045,350)	(8,481,338)
Net loss	(2,220,661)	(4,549,508)	(5,045,350)	(8,481,338)
Preferred Stock dividend and cash premiums	(1,051,695)	(339,232)	(1,863,998)	(339,232)
Preferred Stock accretion	(1,974,359)	(1,153,846)	(9,099,230)	(1,153,846)
Net loss attributable to common stockholders	$ (5,246,715)	$ (6,042,586)	$ (16,008,578)	$ (9,974,416)
Net loss per common share
Basic (in dollars per share)	$ (0.53)	$ (2.85)	$ (2.18)	$ (4.73)
Diluted (in dollars per share)	$ (0.53)	$ (2.85)	$ (2.18)	$ (4.73)
Weighted average common shares outstanding
Basic (in shares)	9,829,793	2,119,620	7,332,030	2,108,747
Diluted (in shares)	9,829,793	2,119,620	7,332,030	2,108,747

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($)	Convertible Redeemable Preferred Stock Preferred Stock Private Placement	Convertible Redeemable Preferred Stock Preferred Stock	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Increase (Decrease) in Temporary Equity
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003 (in shares)	15,000
Series A Preferred Stock accretion		$ 1,153,846
Series A Preferred Stock dividends		249,701
Preferred Stock redemption including cash premium		$ (1,279,016)
Preferred Stock redemption including cash premium (in shares)		(1,154)
Balance at the end at Sep. 30, 2023		$ 124,531
Balance at the end (in shares) at Sep. 30, 2023		13,846
Balance at the beginning at Dec. 31, 2022			$ 208	$ 107,428,652	$ (90,726,393)	$ 16,702,467
Balance at the beginning (in shares) at Dec. 31, 2022			2,079,387
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense				204,492		204,492
Shares issued for vested RSU's			$ 3	(3)
Shares issued for vested RSU's (in shares)			40,233
Series A Preferred Stock accretion				(1,153,846)		(1,153,846)
Series A Preferred Stock dividends				(249,701)		(249,701)
Preferred Stock redemption including cash premium				(89,531)		(89,531)
Net loss					(8,481,338)	(8,481,338)
Balance at the end at Sep. 30, 2023			$ 211	106,140,063	(99,207,731)	6,932,543
Balance at the end (in shares) at Sep. 30, 2023			2,119,620
Increase (Decrease) in Temporary Equity
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003 (in shares)	15,000
Series A Preferred Stock accretion		$ 1,153,846
Series A Preferred Stock dividends		249,701
Preferred Stock redemption including cash premium		$ (1,279,016)
Preferred Stock redemption including cash premium (in shares)		(1,154)
Balance at the end at Sep. 30, 2023		$ 124,531
Balance at the end (in shares) at Sep. 30, 2023		13,846
Balance at the beginning at Jun. 30, 2023			$ 211	107,602,301	(94,658,223)	12,944,289
Balance at the beginning (in shares) at Jun. 30, 2023			2,119,620
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense				30,840		30,840
Series A Preferred Stock accretion				(1,153,846)		(1,153,846)
Series A Preferred Stock dividends				(249,701)		(249,701)
Preferred Stock redemption including cash premium				(89,531)		(89,531)
Net loss					(4,549,508)	(4,549,508)
Balance at the end at Sep. 30, 2023			$ 211	106,140,063	(99,207,731)	6,932,543
Balance at the end (in shares) at Sep. 30, 2023			2,119,620
Balance at the beginning at Dec. 31, 2023		$ 408,982				$ 408,982
Balance at the beginning (in shares) at Dec. 31, 2023		10,022				10,022
Increase (Decrease) in Temporary Equity
Series A Preferred Stock accretion		$ 9,099,230
Series A Preferred Stock dividends		991,783
Preferred Stock redemption including cash premium		$ (10,498,597)
Preferred Stock redemption including cash premium (in shares)		(8,983)
Balance at the end at Sep. 30, 2024		$ 1,398				$ 1,398
Balance at the end (in shares) at Sep. 30, 2024		1,039				1,039
Balance at the beginning at Dec. 31, 2023			$ 298	110,960,324	(98,889,581)	$ 12,071,041
Balance at the beginning (in shares) at Dec. 31, 2023			2,991,377
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense				197,215		197,215
Common Stock issued for services			$ 47	269,953		270,000
Common Stock issued for services (in shares)			459,972
Series A Preferred Stock accretion				(9,099,230)		(9,099,230)
Series A Preferred Stock dividends				(991,783)		(991,783)
Preferred Stock redemption including cash premium			$ 657	6,585,376		6,586,033
Preferred Stock redemption including cash premium (in shares)			6,563,523
Deemed dividends on Preferred Stock				(872,215)		(872,215)
Net loss					(5,045,350)	(5,045,350)
Balance at the end at Sep. 30, 2024			$ 1,002	107,049,640	(103,934,931)	3,115,711
Balance at the end (in shares) at Sep. 30, 2024			10,014,872
Balance at the beginning at Jun. 30, 2024		$ 1,115,762
Balance at the beginning (in shares) at Jun. 30, 2024		4,039
Increase (Decrease) in Temporary Equity
Series A Preferred Stock accretion		$ 1,974,359
Series A Preferred Stock dividends		236,821
Preferred Stock redemption including cash premium		$ (3,325,544)
Preferred Stock redemption including cash premium (in shares)		(3,000)
Balance at the end at Sep. 30, 2024		$ 1,398				$ 1,398
Balance at the end (in shares) at Sep. 30, 2024		1,039				1,039
Balance at the beginning at Jun. 30, 2024			$ 930	109,783,623	(101,714,270)	$ 8,070,283
Balance at the beginning (in shares) at Jun. 30, 2024			9,297,538
Increase (Decrease) in Stockholders' Equity
Common Stock issued for services			$ 14	59,986		60,000
Common Stock issued for services (in shares)			136,986
Series A Preferred Stock accretion				(1,974,359)		(1,974,359)
Series A Preferred Stock dividends				(236,821)		(236,821)
Preferred Stock redemption including cash premium			$ 58	232,085		232,143
Preferred Stock redemption including cash premium (in shares)			580,348
Deemed dividends on Preferred Stock				(814,874)		(814,874)
Net loss					(2,220,661)	(2,220,661)
Balance at the end at Sep. 30, 2024			$ 1,002	$ 107,049,640	$ (103,934,931)	$ 3,115,711
Balance at the end (in shares) at Sep. 30, 2024			10,014,872

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Parenthetical) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023
Series A Preferred Stock
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs	$ 15,000,003	$ 15,000,003

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (5,045,350)	$ (8,481,338)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,175,126	2,480,385
Bad debt expense	16,579	32,516
Inventory and sample inventory reserve	(35,055)	41,195
Amortization of right of use asset	101,328	97,622
Derivative liability	(3,550,000)	430,000
Warrant liability		(11,739,000)
Loss on issuance of Series A Preferred Stock		11,088,997
Noncash Warrant expense		1,595,000
Employee stock-based compensation	197,215	204,492
Stock issued for services	270,000
Changes in operating assets and liabilities:
Accounts receivable	260,959	(897,289)
Inventories	239,795	(63,191)
Prepaid inventory	(466,313)
Prepaid expenses and other current assets	1,386,593	359,492
Accounts payable	(112,287)	(451,338)
Accrued expenses	1,179,294	234,364
Deferred revenue	(46,895)	(281,372)
Other current liabilities	(93,620)	94,113
Other long-term liabilities	(45,825)	(111,283)
Net cash used in operating activities	(3,568,456)	(5,366,635)
Cash flows from investing activities:
Acquisition of fixed assets	(19,138)
Net cash used in investing activities	(19,138)
Cash flows from financing activities:
Payment of promissory note	(765,279)	(1,089,683)
Proceeds from Private Placement, net of transactions costs		15,000,003
Redemption of Series A Preferred Stock	(5,089,417)
Net cash provided by (used in) financing activities	(5,854,696)	13,910,320
Net increase (decrease) in cash	(9,442,290)	8,543,685
Cash, beginning of period	13,336,975	9,426,264
Cash, end of period	3,894,685	17,969,949
Supplemental cash flow information:
Cash paid for interest during the period	234,721	410,317
Noncash Items:
Noncash increase in inventory due to API reclass		(663,984)
Noncash decrease in API purchase commitment		694,314
Noncash decrease in other current assets: API purchase commitment		(30,330)
Noncash issuance of common stock to non-employee		3
Noncash initial fair value of warrant liability pursuant to private placement		21,544,000
Noncash initial fair value of derivative liability pursuant to private placement		6,140,000
Noncash redemption of Series A Preferred Stock	6,586,033
Accrued Series A Convertible Preferred payments payable	1,742,918	1,368,546
Accretion of Series A convertible preferred stock to redemption value	9,099,230	1,153,846
Accrual of Series convertible preferred stock dividends	$ 991,783	$ 339,232

Nature of Operations, Basis of Presentation, Liquidity and Going Concern

9 Months Ended

Sep. 30, 2024

Nature of Operations, Basis of Presentation, Liquidity and Going Concern

Nature of Operations, Basis of Presentation, Liquidity and Going Concern

1) Nature of Operations, Basis of Presentation, Liquidity and Going Concern

Nature of Operations

The Company’s priority is the ability to develop Stendra® OTC and its commercialization.

Basis of Presentation and Principles of Consolidation

Liquidity, Going Concern and Other Uncertainties

NASDAQ Capital Market Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2) Summary of Significant Accounting Policies

Use of Estimates

Risks and Uncertainties

Concentration of Credit Risk

Segment Reporting

Revenue Recognition

Prescription Medication Sales

Product Returns

Contract Rebates, Coupon Redemptions and DSA Fees

Medical Device Sales

Product Returns

Contract Costs

Contract Liabilities

Fair Value of Financial Instruments

Level 1 – Quoted prices in active markets for identical assets or liabilities.

Intangible Assets

Derivative Financial Instruments

Preferred Stock

Recent Accounting Pronouncements

Accounting Pronouncements Not Yet Adopted

Accounts Receivable, net

9 Months Ended

Sep. 30, 2024

Accounts Receivable, net

Accounts Receivable, net

3) Accounts Receivable, net

Accounts receivable, net is comprised of the following:


	September 30,		December 31,
	2024		2023
Gross accounts receivables	$	2,299,300	$	2,887,317
Distribution service fees		(114,073)		(398,968)
Chargebacks accrual		(2,946)		(2,462)
Cash discount allowances		(26,066)		(24,639)
Allowance for credit losses		(207,602)		(235,097)
Total accounts receivable, net	$	1,948,613	$	2,226,151

Inventories

9 Months Ended

Sep. 30, 2024

Inventories

Inventories

4) Inventories

Inventory is comprised of the following:


	September 30, 2024		December 31, 2023
Raw Materials	$	1,257,152	$	1,430,139
Finished goods		148,499		180,252
Total inventory	$	1,405,651	$	1,610,391

Finished goods are net of valuation reserves of $260,356 and $295,411 as of September 30, 2024, and December 31, 2023, respectively.

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2024

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

5) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets are comprised of the following:


	September 30, 2024		December 31, 2023
Prepaid insurance	$	94,030	$	45,664
Prepaid FDA fees		—		937,652
Prepaid R&D expenses		208,900		115,755
API purchase commitment asset (see Note 13)		1,417,348		704,729
Other prepaid expenses		101,281		118,704
Other current assets		4,760		111,476
Total prepaid expenses and other current assets	$	1,826,319	$	2,033,980

Intangible Assets

9 Months Ended

Sep. 30, 2024

Intangible Assets

Intangible Assets

6) Intangible Assets

Intangible Assets are comprised of the following:


Balance at December 31, 2022	$	12,244,484
Amortization expense		(3,272,747)
Balance at December 31, 2023		8,971,737
Amortization expense		(2,145,850)
Balance at September 30, 2024	$	6,825,887

The future annual amortization related to the Company’s intangible assets is as follows as of September 30, 2024:


2024 (remaining 3 months)	$	654,774
2025		1,754,329
2026		1,442,186
2027		1,212,871
2028		996,636
Thereafter		765,091
Total	$	6,825,887

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Accrued Expenses

7) Accrued Expenses

Accrued expenses are comprised of the following:


	September 30, 2024		December 31, 2023
Accrued product returns	$	5,299,261	$	4,178,176
Accrued contract rebates		96,465		128,562
Due to 3PL/Wholesalers		62,284		75,727
Accrued bonuses		501,988		665,184
Accrued professional fees		—		15,000
Accrued R&D fees		354,908		100,668
Other accrued expenses		224,465		196,760
Total accrued expenses	$	6,539,371	$	5,360,077

Debt

9 Months Ended

Sep. 30, 2024

Debt

Debt

8) Debt

Promissory Note

Future minimum principal payments of the Note are as follows:


2024 (remaining 3 months)	$	391,271
2025		2,720,940
2026		3,264,351
2027		872,073
Total	$	7,248,635
Less: current portion		(2,326,050)
Promissory note, net of current portion	$	4,922,585

Stockholders' Equity

9 Months Ended

Sep. 30, 2024

Stockholders' Equity

Stockholders' Equity

9) Stockholders’ Equity

Stock Options

9 Months Ended

Sep. 30, 2024

Stock Options.

Stock Options

10) Stock Options

The following is a summary of stock options for the nine months ended September 30, 2024:


				Weighted-Average
		Weighted-		Remaining	Aggregate Intrinsic
	Number of	Average		Contractual	Value
	Shares	Exercise Price		Term (Years)	($ in thousands)
Options outstanding at December 31, 2023	509,133	$	4.75	9.46	$	66
Options granted	—		—	—		—
Less: options forfeited	—		—	—		—
Less: options expired/cancelled	—		—	—		—
Less: options exercised	—		—	—		—
Options outstanding at September 30, 2024	509,133	$	4.75	8.71	$	—
Options exercisable at September 30, 2024	454,600	$	5.15	8.65	$	—

Common Stock Warrants

9 Months Ended

Sep. 30, 2024

Common Stock Warrants

Common Stock Warrants

11) Common Stock Warrants

The following is a summary of warrants for the nine months ended September 30, 2024:


					Aggregate
					Intrinsic
		Weighted-Average		Remaining	Value ($ in
	Number of Warrants	Exercise Price		Contractual Term	thousands)
Warrants outstanding - December 31, 2023	8,203,839	$	14.93	4.3	$	—
Warrants issued	—		—	—		—
Warrants exercised	—		—	—		—
Warrants expired	(15,097)		252.53	—		—
Warrants outstanding and exercisable- September 30, 2024	8,188,742	$	14.49	3.5	$	—

Dilutive convertible securities

9 Months Ended

Sep. 30, 2024

Dilutive convertible securities

Dilutive convertible securities

12) Dilutive convertible securities


	For the Three Months Ended		For the Nine Months Ended
	September 30,		September 30,
	2024	2023	2024	2023
Stock Options	509,133	210,067	509,133	210,067
Series A Convertible Preferred stock	560,171	6,762,090	560,171	6,762,090
Warrants	8,188,742	8,204,117	8,188,742	8,204,117
Total	9,258,046	15,176,274	9,258,046	15,176,274

Marketing, Licensing and Distribution Agreements

9 Months Ended

Sep. 30, 2024

Marketing, Licensing and Distribution Agreements.

Marketing, Licensing and Distribution Agreements

13) Marketing, Licensing and Distribution Agreements

(a) Vivus

(b) Patheon

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies.

Commitments and Contingencies

14) Commitments and Contingencies

(a) Legal Proceedings

(b) Contract Research

Segment Information

9 Months Ended

Sep. 30, 2024

Segment Information

Segment Information

15) Segment Information

The Company’s results of operations by reportable segment for the nine months ended September 30, 2024, are summarized as follows:


	Prescription		Medical
For the Nine Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	2,086,180	$	2,300,460	$	—	$	4,386,640
Cost of goods sold		194,035		753,911		—		947,946
Selling, general and administrative expenses		1,774,594		1,673,122		3,851,675		7,299,391
Research and development expenses		2,513,105		—		—		2,513,105
Depreciation and amortization expense		1,522,207		652,919		—		2,175,126
Change in fair value of derivative liability		—		—		(3,550,000)		(3,550,000)
Interest income		—		—		(347,028)		(347,028)
Interest expense		—		—		393,450		393,450
Net loss	$	(3,917,761)	$	(779,492)	$	(348,097)	$	(5,045,350)

The Company’s results of operations by reportable segment for the nine months ended September 30, 2023, are summarized as follows:


	Prescription		Medical
For the Nine Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	3,416,444	$	2,770,194	$	—	$	6,186,638
Cost of goods sold		343,109		1,129,964		—		1,473,073
Selling, general and administrative expenses		1,006,666		1,398,890		3,976,610		6,382,166
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		1,499,842		74,918		—		1,574,760
Depreciation and amortization expense		1,726,409		753,976		—		2,480,385
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(287,722)		(287,722)
Interest expense		—		—		410,317		410,317
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(1,159,582)	$	(587,554)	$	(6,734,202)	$	(8,481,338)

The Company’s results of operations by reportable segment for the three months ended September 30, 2024, are summarized as follows:


	Prescription		Medical
For the Three Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	858,063	$	718,303	$	—	$	1,576,366
Cost of goods sold		48,707		238,298		—		287,005
Selling, general and administrative expenses		471,669		600,565		1,229,071		2,301,305
Research and development expenses		588,355		—		—		588,355
Depreciation and amortization expense		521,597		217,852		—		739,449
Change in fair value of derivative liability		—		—		(202,000)		(202,000)
Interest income		—		—		(75,817)		(75,817)
Interest expense		—		—		158,730		158,730
Net loss	$	(772,265)	$	(338,412)	$	(1,109,984)	$	(2,220,661)

The Company’s results of operations by reportable segment for the three months ended September 30, 2023, are summarized as follows:


	Prescription		Medical
For the Three Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	925,759	$	748,898	$	—	$	1,674,657
Cost of goods sold		85,388		323,087		—		408,475
Selling, general and administrative expenses		251,674		493,447		1,256,814		2,001,935
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		369,505		19,588		—		389,093
Depreciation and amortization expense		575,470		251,325		—		826,795
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(168,481)		(168,481)
Interest expense		—		—		131,351		131,351
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(356,278)	$	(338,549)	$	(3,854,681)	$	(4,549,508)

The following table reflects net sales by geographic region for the three and nine months ended September 30, 2024, and 2023:


	For the Three Months Ended				For the Nine Months Ended
	September 30,				September 30,
Net sales	2024		2023		2024		2023
United States	$	1,397,969	$	1,496,988	$	3,682,248	$	5,253,587
International		178,397		177,669		704,392		933,051
	$	1,576,366	$	1,674,657	$	4,386,640	$	6,186,638

No individual country other than the United States accounted for 10% of total sales for the three and nine months ended September 30, 2024, and 2023.

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of September 30, 2024, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	3,410,499	$	3,415,388	$	6,825,887
Total segment assets	$	15,640,046	$	5,053,584	$	20,693,630

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2023, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	4,903,749	$	4,067,988	$	8,971,737
Total segment assets	$	27,891,180	$	5,904,615	$	33,795,795

Private Placement

9 Months Ended

Sep. 30, 2024

Private Placement.

Private Placement

16) Private Placement

Series A Preferred Stock

of 4.83%, a discounted market interest rate of 12.5%, dividend rate of 8.0%, a penalty dividend rate of 15.0%, and probability of default of 4.0%.

Fair Value Measurements

9 Months Ended

Sep. 30, 2024

Fair Value Measurements

Fair Value Measurements

17) Fair Value Measurements

Fair Value on a Recurring Basis


		September 30,
Description	Level	2024
Liabilities:
Bifurcated embedded derivative liability	3	$	—

The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis:


Balance on December 31, 2023	$	3,550,000
Change in fair value of bifurcated embedded derivative		(3,550,000)
Balance on September 30, 2024	$	—

Restatement of Previously Issued Financial Statements

9 Months Ended

Sep. 30, 2024

Restatement of Previously Issued Financial Statements

Restatement of Previously Issued Financial Statements

18) Restatement of Previously Issued Financial Statements

●

The Company’s prior accounting for the Preferred Stock accretion did not have any effect on the Company’s previously reported cash flows or cash.

The following tables summarize the effect of the restatement on each financial statement line item as of the dates, and for the period, indicated:

For the three months ended, September 30, 2023:


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(4,888,740)		(1,153,846)		(6,042,586)
Net loss per share, basic and diluted	$	(2.31)	$	(0.54)	$	(2.85)

For the nine months ended, September 30, 2023:


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(8,820,570)		(1,153,846)		(9,974,416)
Net loss per share, basic and diluted	$	(4.18)	$	(0.55)	$	(4.73)


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF CASH FLOWS	2023				2023
	As Reported		Adjustment		As Restated
Supplemental disclosure of cash flows information
Accretion of Series A convertible preferred stock to redemption value	$	1,250,000	$	(96,154)	$	1,153,846

Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events

Subsequent Events

19) Subsequent Events

On October 11, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing a Certificate of Amendment with the Secretary of State of the State of Delaware . The October 2024 Certificate of Amendment amends the Certificate of Designations to, among other things, provide that, except as required by applicable law, the holders of the Series A Preferred Stock will be entitled to vote with holders of the Common Stock on an as converted basis, with the number of votes to which each holder of Series A Preferred Stock is entitled to be determined by dividing the Stated Value by a conversion price equal to $2.25 per share, which was the “Minimum Price” (as defined in Nasdaq Listing Rule 5635(d)) applicable immediately before the execution and delivery of the Purchase Agreement, subject to certain beneficial ownership limitations and adjustments for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions, as set forth in the Certificate of Designations. The October 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of October 11, 2024.

On November 13, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations of the Company’s Series A Preferred Stock, as described below, by filing the November 2024 Certificate of Amendment with the Secretary of State of the State of Delaware, (ii) defer any payment amounts that have accrued and that are unpaid as of November 13, 2024 pursuant to the Certificate of Designations, to January 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company’s failure to pay such outstanding amounts. The November 2024 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to January 15, 2025, (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations), and (iii) adds an additional restrictive covenant to the Certificate of Designations requiring the Company from November 13, 2024 until January 15, 2025, to maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $1,500,000. The November 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of November 13, 2024.

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Summary of Significant Accounting Policies
Use of Estimates	Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenue and expenses during the reporting periods. Such estimates include the adequacy of accounts receivable reserves, return reserves, inventory reserves, assessment of long-lived assets, including intangible asset impairment, and the valuation of the derivative liability, among others. Actual results could differ from these estimates and changes in these estimates are recorded when known.
Risks and Uncertainties	Risks and Uncertainties The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of competitor products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, and protection of intellectual property rights.
Concentration of Credit Risk	Concentration of Credit Risk Financial instruments that subject the Company to concentrations of credit risk includes cash. The Company maintains cash on deposit at U.S.-based banks in amounts which, at times, may be in excess of insured limits of $250,000.
Segment Reporting	Segment Reporting Operating segments are components of a Company for which separate financial information is available and evaluated regularly by the chief operating decision maker in assessing performance and deciding how to allocate resources. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of ED. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States. The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. See Note 15 Segment Information.
Revenue Recognition	Revenue Recognition Prescription Medication Sales The Company’s prescription medication sales consist of sales of Stendra® in the U.S. for the treatment of ED. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue Recognition (“Topic 606”), the Company recognizes revenue from prescription medication sales when its performance obligations with a customer have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide Stendra® upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of Stendra®, which is typically upon delivery. The Company invoices its customers after Stendra® has been delivered and invoice payments are generally due within 30 to 75 days of invoice date. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers Stendra® to when the customers pay for the product is typically less than one year. The Company records prescription medication sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and distribution service fees (“DSA”). The Company uses the expected value method when estimating its variable consideration, unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales of Stendra® are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. As of September 30, 2024, and December 31, 2023, the reserves for sales deductions were $5.5 million and $4.7 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and DSA fees. The Company’s estimates are based on factors such as direct and indirect customers’ buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with the Company’s direct and indirect customers, and other competitive factors. Significant judgment and estimation are required in developing the foregoing and other relevant assumptions. The most significant sales deductions are further described below. Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return Stendra® and receive credit for product within six months prior to expiration date and up to one year after expiration date. The provision for returns is based upon the Company’s estimates for future Stendra® returns and historical experience. The provision of returns is part of the variable consideration recorded at the time revenue is recognized. As of September 30, 2024, and December 31, 2023, the reserves for product returns were $5.3 million and $4.2 million, respectively, and are included as a component of accrued expenses. During the nine months ended September 30, 2024, and 2023, the Company recorded $1.2 million and $1.3 million, respectively, of returns as a reduction of gross revenue. During the three months ended September 30, 2024, and 2023, the Company recorded $0.4 million and $0.5 million, respectively, of returns as a reduction of gross revenue. Contract Rebates, Coupon Redemptions and DSA Fees The Company establishes contracts with wholesalers, chain stores, and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under the Company’s DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with us. The Company has entered into DSAs with certain significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for the Company’s pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves. Medical Device Sales The Company’s medical device sales consist of domestic and international sales of men’s health products for the treatment of ED. The men’s health products do not require a prescription and include vacuum erection devices, PreBoost, VenoSeal, penile injections (Rx), and urinary tract infection tests. Under Topic 606, the Company recognizes revenue from medical device sales when its performance obligations with its customers have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide medical devices upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the medical device, which is typically upon shipment. The Company invoices its customers after the medical devices have been shipped and invoice payments are generally due within 30 days of invoice date for domestic customers and 90 days for international customers. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers the medical devices to when the customers pay for the product is typically less than one year. The Company records medical device sales net of any variable consideration, including but not limited to returns. The Company uses the expected value method when estimating its variable consideration. The identified variable consideration is recorded as a reduction of revenue at the time revenues from the medical device sales are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return medical devices and receive credit for products within 90 days of the sale. The provision for returns is based upon the Company’s estimates for future product returns and historical experience. The Company has not made significant changes to the judgments made in applying Topic 606. As of September 30, 2024, and December 31, 2023, the reserves for product returns for medical devices were not significant. Contract Costs In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred. As such, the Company did not have any contract assets at September 30, 2024, and December 31, 2023. Contract Liabilities Under Accounting Standards Codification Topic 606, Revenue Recognition, the Company recognizes revenue when its performance obligations with a customer has been satisfied. In the event it has not been satisfied, the Company records deferred revenue as a liability on the balance sheet. As of September 30, 2024, and December 31, 2023, deferred revenue was $0.1 million and $0.1 million, respectively.
Fair Value of Financial Instruments	Fair Value of Financial Instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market. Level 3 – Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. Financial instruments recognized at historical amounts in the consolidated balance sheets consist of cash, accounts receivable, other current assets, accounts payable, accrued expenses, and other current liabilities. The Company believes that the carrying values of cash, accounts receivable, other current assets, accounts payable, accrued expenses, note payable, and other current liabilities approximate their fair values due to the short-term nature of these instruments. In connection with the Private Placement (as defined herein), the Company incurred liabilities related to derivatives arising from embedded features that were not clearly and closely related to the host instruments. The Company estimated the fair value of derivative liability utilizing Monte Carlo Simulation approach. These fair value measurements are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. See Notes 16 and 17.
Intangible Assets	Intangible Assets The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life that the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are amortized using an accelerated method based on the pattern in which the economic benefits of the assets are consumed. The Company reviews the carrying value and useful lives of its intangible assets with definite lives whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or the period over which they should be amortized has changed. When indicators of impairment exist, the Company determines whether the estimated undiscounted sum of the future cash flows of such assets is less than their carrying amounts. If less, an impairment loss is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values. The Company evaluates the remaining useful life of each intangible asset that is being amortized during each reporting period to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life. The Company’s prepared projections including the undiscounted cash flows of the remaining estimated useful lives through December 2031 for the medical device products. Management continued to analyze the Company’s intangible assets during 2024. Management noted that the Company’s financial results were consistent with previous projections. Based on its analysis, Management concluded that there were no triggering events noted that would indicate a potential impairment for long-lived assets for any of the two asset groups, Metuchen Pharmaceuticals and TIMM/PTV.
Derivative Financial Instruments	Derivative Financial Instruments The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging (“ASC 815”). Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations each period. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet.
Preferred Stock	Preferred Stock The Company records shares of convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company concluded that the Series A Preferred Stock is more akin to a debt-type instrument than an equity-type instrument, therefore certain conversion features associated with the convertible preferred stock were deemed to not be clearly and closely related to the host instrument and were bifurcated as a derivative under ASC 815. The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities and has therefore classified the Series A convertible preferred stock as mezzanine equity as it redeemable in monthly installments. The Company adjusts the carrying values of the convertible preferred stock by accreting the discount and accruing dividends to the state the convertible preferred stock at redemption value each reporting period.
Recent Accounting Pronouncements	Recent Accounting Pronouncements Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance will be effective for the annual periods beginning the year ended December 31, 2024, and for interim periods beginning January 1, 2025. Early adoption is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating segment disclosures related to its annual report for fiscal year 2024. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company is currently evaluating income tax disclosures related to its annual report for fiscal year 2025. In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures.

Accounts Receivable, net (Tables)

9 Months Ended

Sep. 30, 2024

Accounts Receivable, net

Schedule of accounts receivable


	September 30,		December 31,
	2024		2023
Gross accounts receivables	$	2,299,300	$	2,887,317
Distribution service fees		(114,073)		(398,968)
Chargebacks accrual		(2,946)		(2,462)
Cash discount allowances		(26,066)		(24,639)
Allowance for credit losses		(207,602)		(235,097)
Total accounts receivable, net	$	1,948,613	$	2,226,151

Inventories (Tables)

9 Months Ended

Sep. 30, 2024

Inventories

Schedule of inventories


	September 30, 2024		December 31, 2023
Raw Materials	$	1,257,152	$	1,430,139
Finished goods		148,499		180,252
Total inventory	$	1,405,651	$	1,610,391

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2024

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	September 30, 2024		December 31, 2023
Prepaid insurance	$	94,030	$	45,664
Prepaid FDA fees		—		937,652
Prepaid R&D expenses		208,900		115,755
API purchase commitment asset (see Note 13)		1,417,348		704,729
Other prepaid expenses		101,281		118,704
Other current assets		4,760		111,476
Total prepaid expenses and other current assets	$	1,826,319	$	2,033,980

Intangible Assets (Tables)

9 Months Ended

Sep. 30, 2024

Intangible Assets

Schedule of intangible assets


Balance at December 31, 2022	$	12,244,484
Amortization expense		(3,272,747)
Balance at December 31, 2023		8,971,737
Amortization expense		(2,145,850)
Balance at September 30, 2024	$	6,825,887

Schedule of future annual amortization related to the company's intangible assets

The future annual amortization related to the Company’s intangible assets is as follows as of September 30, 2024:


2024 (remaining 3 months)	$	654,774
2025		1,754,329
2026		1,442,186
2027		1,212,871
2028		996,636
Thereafter		765,091
Total	$	6,825,887

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Schedule of accrued expenses


	September 30, 2024		December 31, 2023
Accrued product returns	$	5,299,261	$	4,178,176
Accrued contract rebates		96,465		128,562
Due to 3PL/Wholesalers		62,284		75,727
Accrued bonuses		501,988		665,184
Accrued professional fees		—		15,000
Accrued R&D fees		354,908		100,668
Other accrued expenses		224,465		196,760
Total accrued expenses	$	6,539,371	$	5,360,077

Debt (Tables)

9 Months Ended

Sep. 30, 2024

Debt

Schedule of future principal payments of the promissory note


2024 (remaining 3 months)	$	391,271
2025		2,720,940
2026		3,264,351
2027		872,073
Total	$	7,248,635
Less: current portion		(2,326,050)
Promissory note, net of current portion	$	4,922,585

Stock Options (Tables)

9 Months Ended

Sep. 30, 2024

Stock Options.

Schedule of stock options


				Weighted-Average
		Weighted-		Remaining	Aggregate Intrinsic
	Number of	Average		Contractual	Value
	Shares	Exercise Price		Term (Years)	($ in thousands)
Options outstanding at December 31, 2023	509,133	$	4.75	9.46	$	66
Options granted	—		—	—		—
Less: options forfeited	—		—	—		—
Less: options expired/cancelled	—		—	—		—
Less: options exercised	—		—	—		—
Options outstanding at September 30, 2024	509,133	$	4.75	8.71	$	—
Options exercisable at September 30, 2024	454,600	$	5.15	8.65	$	—

Common Stock Warrants (Tables)

9 Months Ended

Sep. 30, 2024

Common Stock Warrants

Summary of warrants


					Aggregate
					Intrinsic
		Weighted-Average		Remaining	Value ($ in
	Number of Warrants	Exercise Price		Contractual Term	thousands)
Warrants outstanding - December 31, 2023	8,203,839	$	14.93	4.3	$	—
Warrants issued	—		—	—		—
Warrants exercised	—		—	—		—
Warrants expired	(15,097)		252.53	—		—
Warrants outstanding and exercisable- September 30, 2024	8,188,742	$	14.49	3.5	$	—

Dilutive convertible securities (Tables)

9 Months Ended

Sep. 30, 2024

Dilutive convertible securities

Summary of potentially dilutive securities convertible into common shares


	For the Three Months Ended		For the Nine Months Ended
	September 30,		September 30,
	2024	2023	2024	2023
Stock Options	509,133	210,067	509,133	210,067
Series A Convertible Preferred stock	560,171	6,762,090	560,171	6,762,090
Warrants	8,188,742	8,204,117	8,188,742	8,204,117
Total	9,258,046	15,176,274	9,258,046	15,176,274

Segment Information (Tables)

9 Months Ended

Sep. 30, 2024

Segment Information

Schedule of results of operations by reportable segment


	Prescription		Medical
For the Nine Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	2,086,180	$	2,300,460	$	—	$	4,386,640
Cost of goods sold		194,035		753,911		—		947,946
Selling, general and administrative expenses		1,774,594		1,673,122		3,851,675		7,299,391
Research and development expenses		2,513,105		—		—		2,513,105
Depreciation and amortization expense		1,522,207		652,919		—		2,175,126
Change in fair value of derivative liability		—		—		(3,550,000)		(3,550,000)
Interest income		—		—		(347,028)		(347,028)
Interest expense		—		—		393,450		393,450
Net loss	$	(3,917,761)	$	(779,492)	$	(348,097)	$	(5,045,350)


	Prescription		Medical
For the Nine Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	3,416,444	$	2,770,194	$	—	$	6,186,638
Cost of goods sold		343,109		1,129,964		—		1,473,073
Selling, general and administrative expenses		1,006,666		1,398,890		3,976,610		6,382,166
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		1,499,842		74,918		—		1,574,760
Depreciation and amortization expense		1,726,409		753,976		—		2,480,385
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(287,722)		(287,722)
Interest expense		—		—		410,317		410,317
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(1,159,582)	$	(587,554)	$	(6,734,202)	$	(8,481,338)


	Prescription		Medical
For the Three Months Ended September 30, 2024	Medications		Devices		Corporate		Consolidated
Net sales	$	858,063	$	718,303	$	—	$	1,576,366
Cost of goods sold		48,707		238,298		—		287,005
Selling, general and administrative expenses		471,669		600,565		1,229,071		2,301,305
Research and development expenses		588,355		—		—		588,355
Depreciation and amortization expense		521,597		217,852		—		739,449
Change in fair value of derivative liability		—		—		(202,000)		(202,000)
Interest income		—		—		(75,817)		(75,817)
Interest expense		—		—		158,730		158,730
Net loss	$	(772,265)	$	(338,412)	$	(1,109,984)	$	(2,220,661)


	Prescription		Medical
For the Three Months Ended September 30, 2023	Medications		Devices		Corporate		Consolidated
Net sales	$	925,759	$	748,898	$	—	$	1,674,657
Cost of goods sold		85,388		323,087		—		408,475
Selling, general and administrative expenses		251,674		493,447		1,256,814		2,001,935
Warrant issuance costs		—		—		2,855,000		2,855,000
Research and development expenses		369,505		19,588		—		389,093
Depreciation and amortization expense		575,470		251,325		—		826,795
Change in fair value of derivative liability		—		—		430,000		430,000
Change in fair value of warrant liability		—		—		(11,739,000)		(11,739,000)
Interest income		—		—		(168,481)		(168,481)
Interest expense		—		—		131,351		131,351
Loss on issuance of Series A Preferred Stock		—		—		11,088,997		11,088,997
Net loss	$	(356,278)	$	(338,549)	$	(3,854,681)	$	(4,549,508)

Schedule of net sales by geographic region


	For the Three Months Ended				For the Nine Months Ended
	September 30,				September 30,
Net sales	2024		2023		2024		2023
United States	$	1,397,969	$	1,496,988	$	3,682,248	$	5,253,587
International		178,397		177,669		704,392		933,051
	$	1,576,366	$	1,674,657	$	4,386,640	$	6,186,638

Schedule of assets by reportable segment and reconciliation of segment assets to consolidated assets

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of September 30, 2024, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	3,410,499	$	3,415,388	$	6,825,887
Total segment assets	$	15,640,046	$	5,053,584	$	20,693,630

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2023, are summarized as follows:


	Prescription		Medical
	Medications		Devices		Consolidated
Intangible assets, net	$	4,903,749	$	4,067,988	$	8,971,737
Total segment assets	$	27,891,180	$	5,904,615	$	33,795,795

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Measurements

Schedule of fair value of financial liabilities on recurring basis


		September 30,
Description	Level	2024
Liabilities:
Bifurcated embedded derivative liability	3	$	—

Summary of the change in the fair value of financial liabilities


Balance on December 31, 2023	$	3,550,000
Change in fair value of bifurcated embedded derivative		(3,550,000)
Balance on September 30, 2024	$	—

Restatement of Previously Issued Financial Statements (Tables)

9 Months Ended

Sep. 30, 2024

Restatement of Previously Issued Financial Statements

Schedule of effect of the restatement on each financial statement line item


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(4,888,740)		(1,153,846)		(6,042,586)
Net loss per share, basic and diluted	$	(2.31)	$	(0.54)	$	(2.85)

For the nine months ended, September 30, 2023:


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF OPERATIONS	2023				2023
	As Reported		Adjustment		As Restated
Accretion of Series A convertible preferred stock to redemption value	$	—	$	(1,153,846)	$	(1,153,846)
Net loss attributable to common stockholders		(8,820,570)		(1,153,846)		(9,974,416)
Net loss per share, basic and diluted	$	(4.18)	$	(0.55)	$	(4.73)


CONDENSED CONSOLIDATED	September 30,				September 30,
STATEMENTS OF CASH FLOWS	2023				2023
	As Reported		Adjustment		As Restated
Supplemental disclosure of cash flows information
Accretion of Series A convertible preferred stock to redemption value	$	1,250,000	$	(96,154)	$	1,153,846

Nature of Operations, Basis of Presentation, Liquidity and Going Concern (Details)		1 Months Ended	9 Months Ended
	May 15, 2024 D	Jul. 31, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)	Jan. 31, 2022 USD ($)
Nature of Operations, Basis of Presentation, Liquidity and Going Concern
Cash			$ 3,900,000
Working capital			1,800,000
Accumulated deficit			103,934,931		$ 98,889,581
Principal amount of notes payable			10,201,758
Interest Amount			$ 7,200,000
Proceeds from Private Placement, net of transactions costs		$ 15,000,000		$ 15,000,003
Consecutive business days for maintaining bid price requirement \| D	30
Vivus, Inc \| Settlement Agreement
Nature of Operations, Basis of Presentation, Liquidity and Going Concern
Principal amount of notes payable						$ 10,201,758

Summary of Significant Accounting Policies (Details) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) segment	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)
Summary of Significant Accounting Policies
Number of operating segments \| segment			2
Contract with Customer, Refund Liability, Current	$ 5.3		$ 5.3		$ 4.2
Amount Of Returns As Reduction Of Gross Revenue	0.4	$ 0.5	$ 1.2	$ 1.3
Revenue, Practical Expedient, Financing Component [true false]			true
Deferred revenue	0.1		$ 0.1		0.1
Prescription Medications
Summary of Significant Accounting Policies
Contract With Customer, Sales Deduction	$ 5.5		$ 5.5		$ 4.7
Medical Devices
Summary of Significant Accounting Policies
Contract With Customer, Right to Return and Receive Credit for Product			90 days
Minimum \| Prescription Medications
Summary of Significant Accounting Policies
Due Period for Invoice Payments			30 days
Contract With Customer, Right to Return and Receive Credit for Product			6 months
Minimum \| Medical Devices \| Domestic customers
Summary of Significant Accounting Policies
Due Period for Invoice Payments			30 days
Maximum \| Prescription Medications
Summary of Significant Accounting Policies
Due Period for Invoice Payments			75 days
Contract With Customer, Right to Return and Receive Credit for Product			1 year
Maximum \| Medical Devices \| International Customers
Summary of Significant Accounting Policies
Due Period for Invoice Payments			90 days

Accounts Receivable, net (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Accounts Receivable, net
Gross accounts receivables	$ 2,299,300	$ 2,887,317
Distribution service fees	(114,073)	(398,968)
Chargebacks accrual	(2,946)	(2,462)
Cash discount allowances	(26,066)	(24,639)
Allowance for credit losses	(207,602)	(235,097)
Total accounts receivable, net	$ 1,948,613	$ 2,226,151

Accounts Receivable, net - Additional information (Details) - customer	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Revenue from Contract with Customer Benchmark \| Customer Concentration Risk
Accounts Receivable, net
Number of customers	3	3	3	3
Revenue from Contract with Customer Benchmark \| Customer Concentration Risk \| One customers
Accounts Receivable, net
Concentration risk percentage	30.00%	24.00%	28.00%	23.00%
Revenue from Contract with Customer Benchmark \| Customer Concentration Risk \| Two customers
Accounts Receivable, net
Concentration risk percentage	25.00%	21.00%	25.00%	19.00%
Revenue from Contract with Customer Benchmark \| Customer Concentration Risk \| Three customers
Accounts Receivable, net
Concentration risk percentage	14.00%	18.00%	14.00%	17.00%
Accounts Receivable \| Credit Concentration Risk
Accounts Receivable, net
Number of customers			3		3
Accounts Receivable \| Credit Concentration Risk \| One customers
Accounts Receivable, net
Concentration risk percentage			53.00%		36.00%
Accounts Receivable \| Credit Concentration Risk \| Two customers
Accounts Receivable, net
Concentration risk percentage			25.00%		24.00%
Accounts Receivable \| Credit Concentration Risk \| Three customers
Accounts Receivable, net
Concentration risk percentage			22.00%		16.00%
Net sales \| Stendra \| One customers
Accounts Receivable, net
Concentration risk percentage	94.00%		95.00%

Inventories (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Inventories
Raw Materials	$ 1,257,152	$ 1,430,139
Finished goods	148,499	180,252
Total inventory	$ 1,405,651	$ 1,610,391

Inventories - Additional Information (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Inventories
Finished goods are net of valuation reserves	$ 260,356	$ 295,411

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Prepaid Expenses and Other Current Assets
Prepaid insurance	$ 94,030	$ 45,664
Prepaid FDA fees		937,652
Prepaid R&D expenses	208,900	115,755
API purchase commitment asset (see Note 13)	1,417,348	704,729
Other prepaid expenses	101,281	118,704
Other current assets	4,760	111,476
Total prepaid expenses and other current assets	$ 1,826,319	$ 2,033,980

Intangible Assets (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
Intangible Assets (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Intangible Assets
Balance			$ 8,971,737	$ 12,244,484	$ 12,244,484
Amortization expense	$ (700,000)	$ (800,000)	(2,145,850)	$ (2,500,000)	(3,272,747)
Balance	$ 6,825,887		$ 6,825,887		$ 8,971,737

Intangible Assets - Future annual amortization (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022
Intangible Assets
2024 (remaining 3 months)	$ 654,774
2025	1,754,329
2026	1,442,186
2027	1,212,871
2028	996,636
Thereafter	765,091
Total	$ 6,825,887	$ 8,971,737	$ 12,244,484

Intangible Assets - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Intangible Assets
Carrying value of intangible assets	$ 6,825,887		$ 6,825,887		$ 8,971,737	$ 12,244,484
Amortization expense	$ 700,000	$ 800,000	$ 2,145,850	$ 2,500,000	3,272,747
Stendra product
Intangible Assets
Estimated useful lives of intangible assets	10 years		10 years
Carrying value of intangible assets	$ 3,400,000		$ 3,400,000		4,900,000
Timm Medical product
Intangible Assets
Estimated useful lives of intangible assets	12 years		12 years
Carrying value of intangible assets	$ 2,700,000		$ 2,700,000		3,200,000
PTV product
Intangible Assets
Estimated useful lives of intangible assets	12 years		12 years
Carrying value of intangible assets	$ 700,000		$ 700,000		$ 900,000

Accrued Expenses (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses
Accrued product returns	$ 5,299,261	$ 4,178,176
Accrued contract rebates	96,465	128,562
Due to 3PL/Wholesalers	62,284	75,727
Accrued bonuses	501,988	665,184
Accrued professional fees		15,000
Accrued R&D fees	354,908	100,668
Other accrued expenses	224,465	196,760
Total accrued expenses	$ 6,539,371	$ 5,360,077

Debt - Promissory Note (Details) - USD ($)		9 Months Ended
Debt - Promissory Note (Details) - USD ($)	Oct. 01, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Debt Instrument
Principal amount of notes payable		$ 10,201,758
Subsequent Event [Member]
Debt Instrument
Additional interest expense accrued	$ 50,000
Notes payable
Debt Instrument
Principal amount of notes payable		$ 10,201,758
Interest rate (in percent)		6.00%
Interest rate at the time of default (in percent)		9.00%
Repayments of notes payable		$ 1,000,000.0	$ 1,500,000
Principal balance		$ 7,200,000		$ 8,000,000.0
Notes payable \| Subsequent Event [Member]
Debt Instrument
Interest rate at the time of default (in percent)	9.00%
Payment due pursuant to the note and security agreement	$ 500,000
Additional interest expense accrued	$ 50,000

Debt - Future minimum principal payments (Details) - Promissory note	Sep. 30, 2024 USD ($)
Debt Instrument
2024 (remaining 3 months)	$ 391,271
2025	2,720,940
2026	3,264,351
2027	872,073
Total	7,248,635
Less: current portion	(2,326,050)
Promissory note, net of current portion	$ 4,922,585

Stockholders' Equity - Number of shares held (Details)						1 Months Ended
Stockholders' Equity - Number of shares held (Details)	Aug. 13, 2024 shares	Jun. 21, 2024 shares	Feb. 29, 2024 shares	Jan. 05, 2024 USD ($) shares	Dec. 21, 2023 USD ($) installment	Dec. 31, 2023 shares
Stockholders' Equity
Common Stock issued for services (in shares)						348,711
CorProminence, LLC
Stockholders' Equity
Issuance of common stock \| $					$ 200,000
Number of installments \| installment					2
Common Stock issued for services (in shares)		245,158	70,922
Maxim Group LLC
Stockholders' Equity
Common Stock issued for services (in shares)	136,986			6,906
Restricted common stock per month \| $				$ 10,000

Stock Options - Summary of stock options (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of Shares
Options outstanding at the beginning	509,133
Options outstanding at the end	509,133	509,133
Options exercisable at the end	454,600
Weighted-Average Fair Value at Grant Date
Options outstanding at the beginning (in dollars per share)	$ 4.75
Options outstanding at the end (in dollars per share)	4.75	$ 4.75
Options exercisable at the end (in dollars per share)	$ 5.15
Weighted-Average Remaining Contractual Term (Years) and Aggregate Intrinsic Value
Options outstanding at the beginning (in years)	8 years 8 months 15 days	9 years 5 months 15 days
Options outstanding and exercisable at the beginning (in dollars)		$ 66
Options outstanding at the ending (in years)	8 years 8 months 15 days	9 years 5 months 15 days
Options exercisable at the end (in years)	8 years 7 months 24 days
Options outstanding at the end (in dollars)		$ 66

Stock Options - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock Options.
Stock-based compensation expense	$ 0	$ 30,840	$ 197,215	$ 204,492
Unrecognized stock-based compensation expense	$ 0		$ 0

Common Stock Warrants - Summary of warrants (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of Warrants
Warrants outstanding at the beginning	8,203,839
Warrants expired	(15,097)
Warrants outstanding and exercisable at the end	8,188,742	8,203,839
Weighted Average Exercise Price
Weighted-Average Exercise Price at the beginning (in dollars per share)	$ 14.93
Warrants expired (in dollars per share)	252.53
Weighted-Average Exercise Price at the ending (in dollars per share)	$ 14.49	$ 14.93
Remaining Contractual Term
Warrants outstanding (in years)	3 years 6 months	4 years 3 months 18 days

Dilutive convertible securities - Potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net income (loss) per share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Basic and Diluted Net Loss per Common Share
Total	9,258,046	15,176,274	9,258,046	15,176,274
Stock Options
Basic and Diluted Net Loss per Common Share
Total	509,133	210,067	509,133	210,067
Series A Convertible Preferred stock
Basic and Diluted Net Loss per Common Share
Total	560,171	6,762,090	560,171	6,762,090
Warrants
Basic and Diluted Net Loss per Common Share
Total	8,188,742	8,204,117	8,188,742	8,204,117

Marketing, Licensing and Distribution Agreements - Vivus (Details)			3 Months Ended		9 Months Ended		12 Months Ended
	Jan. 18, 2022 USD ($)	Sep. 30, 2016 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2023 USD ($)	Jan. 31, 2022 USD ($)
Marketing, Licensing and Distribution Agreements
Principal amount of notes payable			$ 10,201,758		$ 10,201,758
Noncash decrease in API purchase commitment						$ 694,314
API purchase commitment asset			1,417,348		1,417,348			$ 704,729
License Agreement \| Royalty on the first $500 million of net sales
Marketing, Licensing and Distribution Agreements
Threshold net sales					500,000,000
License Agreement \| Milestone payment to be paid once $250 million in sales has been reached
Marketing, Licensing and Distribution Agreements
Threshold net sales					250,000,000
Milestone payment			6,000,000		6,000,000
License Agreement \| Milestone payment to be paid after $250 million in sales has been reached
Marketing, Licensing and Distribution Agreements
Threshold net sales					250,000,000
Milestone payment			3,200,000		$ 3,200,000
License Agreement \| Vivus, Inc
Marketing, Licensing and Distribution Agreements
One-time fee to purchase and receive the license for the commercialization and exploitation of Stendra		$ 70,000,000
License Agreement \| Vivus, Inc \| Royalty during the first, second, and third years following the expiration of the Royalty Period
Marketing, Licensing and Distribution Agreements
Royalty percentage					2.00%
License Agreement \| Vivus, Inc \| Royalty following the fourth and fifth years following the end of the Royalty Period
Marketing, Licensing and Distribution Agreements
Royalty percentage					1.00%
License Agreement \| MTPC
Marketing, Licensing and Distribution Agreements
Royalty incurred			42,903	$ 46,288	$ 104,309	$ 170,822
Royalty receivable								56,503
License Agreement \| MTPC \| Accrued liabilities
Marketing, Licensing and Distribution Agreements
Royalty payable			42,903		$ 42,903
License Agreement \| MTPC \| Royalty on the first $500 million of net sales
Marketing, Licensing and Distribution Agreements
Royalty percentage					5.00%
License Agreement \| MTPC \| Royalty on net sales after $500 million
Marketing, Licensing and Distribution Agreements
Royalty percentage					6.00%
Settlement Agreement \| Vivus, Inc
Marketing, Licensing and Distribution Agreements
Inventory amount retained - API	$ 7,300,000
Prepayment amount	900,000
Principal amount of notes payable									$ 10,201,758
Payment made for purchase order	$ 1,542,904
Percentage of stendra tablets released	100
Noncash decrease in accrued expenses related to Vivus settlement	$ 6,500,000
Noncash decrease in accrued inventory purchases related to Vivus Settlement	14,200,000
Noncash decrease in API purchase commitment	6,200,000
Gain on settlement with Vivus							$ 3,400,000
Settlement Agreement \| Vivus, Inc \| Other Current Assets
Marketing, Licensing and Distribution Agreements
API purchase commitment asset			1,400,000		$ 1,400,000			700,000
Settlement Agreement \| Vivus, Inc \| Other Noncurrent Assets
Marketing, Licensing and Distribution Agreements
Accrued inventory purchases, other assets			$ 3,000,000.0		$ 3,000,000.0			$ 4,200,000
Settlement Agreement \| Vivus, Inc \| Promissory Note
Marketing, Licensing and Distribution Agreements
Prepayment amount	900,000
Principal amount of notes payable	$ 10,201,758

Commitments and Contingencies (Details) $ in Millions	Sep. 30, 2024 USD ($)
Commitments and Contingencies
Percentage Of Project work completed	91.00%
Contract Research Organization (CRO)
Commitments and Contingencies
Amount paid for Research contract	$ 1.8

Segment Information (Details)	3 Months Ended		9 Months Ended
Segment Information (Details)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) segment	Sep. 30, 2023 USD ($)
Statements
Number of operating segments \| segment			2
Results of operations by reportable segment
Net sales	$ 1,576,366	$ 1,674,657	$ 4,386,640	$ 6,186,638
Cost of goods sold	287,005	408,475	947,946	1,473,073
Selling, general and administrative expenses	2,301,305	2,001,935	7,299,391	6,382,166
Warrant issuance costs		2,855,000		2,855,000
Research and development expenses	588,355	389,093	2,513,105	1,574,760
Depreciation and amortization expense	739,449	826,795	2,175,126	2,480,385
Change in fair value of derivative liability	(202,000)	430,000	(3,550,000)	430,000
Gain from change in fair value of the warrant liability		(11,739,000)		(11,739,000)
Interest income	(75,817)	(168,481)	(347,028)	(287,722)
Interest expense	158,730	131,351	393,450	410,317
Loss on issuance of Series A Preferred Stock		11,088,997		11,088,997
Net loss	(2,220,661)	(4,549,508)	(5,045,350)	(8,481,338)
Corporate
Results of operations by reportable segment
Selling, general and administrative expenses	1,229,071	1,256,814	3,851,675	3,976,610
Warrant issuance costs		2,855,000		2,855,000
Change in fair value of derivative liability	(202,000)	430,000	(3,550,000)	430,000
Gain from change in fair value of the warrant liability		(11,739,000)		(11,739,000)
Interest income	(75,817)	(168,481)	(347,028)	(287,722)
Interest expense	158,730	131,351	393,450	410,317
Loss on issuance of Series A Preferred Stock		11,088,997		11,088,997
Net loss	(1,109,984)	(3,854,681)	(348,097)	(6,734,202)
Prescription Medications \| Operating segments
Results of operations by reportable segment
Net sales	858,063	925,759	2,086,180	3,416,444
Cost of goods sold	48,707	85,388	194,035	343,109
Selling, general and administrative expenses	471,669	251,674	1,774,594	1,006,666
Research and development expenses	588,355	369,505	2,513,105	1,499,842
Depreciation and amortization expense	521,597	575,470	1,522,207	1,726,409
Net loss	(772,265)	(356,278)	(3,917,761)	(1,159,582)
Medical Devices \| Operating segments
Results of operations by reportable segment
Net sales	718,303	748,898	2,300,460	2,770,194
Cost of goods sold	238,298	323,087	753,911	1,129,964
Selling, general and administrative expenses	600,565	493,447	1,673,122	1,398,890
Research and development expenses		19,588		74,918
Depreciation and amortization expense	217,852	251,325	652,919	753,976
Net loss	$ (338,412)	$ (338,549)	$ (779,492)	$ (587,554)

Segment Information - Net Sales by Geographic region (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statements
Net sales	$ 1,576,366	$ 1,674,657	$ 4,386,640	$ 6,186,638
United States
Statements
Net sales	1,397,969	1,496,988	3,682,248	5,253,587
International
Statements
Net sales	$ 178,397	$ 177,669	$ 704,392	$ 933,051

Segment Information - Segment assets (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Statements
Intangible assets, net	$ 6,825,887	$ 8,971,737
Total segment assets	20,693,630	33,795,795
Prescription Medications
Statements
Intangible assets, net	3,410,499	4,903,749
Total segment assets	15,640,046	27,891,180
Medical Devices
Statements
Intangible assets, net	3,415,388	4,067,988
Total segment assets	$ 5,053,584	$ 5,904,615

Private Placement (Details)		1 Months Ended	3 Months Ended	9 Months Ended
Private Placement (Details)	Jul. 13, 2023 USD ($) installment $ / shares shares	Dec. 31, 2023 $ / shares shares	Sep. 30, 2024 USD ($) Y $ / shares shares	Sep. 30, 2024 USD ($) Y $ / shares shares	Nov. 13, 2024 USD ($)	Oct. 13, 2024 USD ($)	Oct. 11, 2024 $ / shares
Private Placement
Common stock, par value (in dollars per share) \| $ / shares		$ 0.0001	$ 0.0001	$ 0.0001
Exercise price of warrants \| $ / shares	$ 2.25	$ 14.93	$ 14.49	$ 14.49
Common Stock issued for services (in shares) \| shares		348,711
Aggregate common shares in percent		5.00%
Embedded Derivative Liability, Measurement Input			0.125	0.125
Preferred dividends at the stated dividend rate			$ 236,821	$ 991,783
Dividends, Preferred Stock			453,359	1,265,662
Reversal dividends payable of temporary equity at stated value			216,538	273,879
Subsequent Events
Private Placement
Cash and cash equivalents					$ 1,500,000	$ 1,500,000
Embedded derivative instrument
Private Placement
Fair value of the bifurcated embedded derivative			0	0
Derivative, Gain on Derivative			$ 202,000	$ 3,550,000
Fair value of our common stock
Private Placement
Embedded Derivative Liability, Measurement Input			0.0036	0.0036
Equity volatility \| Embedded derivative instrument
Private Placement
Embedded Derivative Liability, Measurement Input			0.600	0.600
Traded volume volatility
Private Placement
Embedded Derivative Liability, Measurement Input			2.300	2.300
Expected term
Private Placement
Embedded Derivative Liability, Measurement Input \| Y			0.17	0.17
Risk-free interest rate
Private Placement
Embedded Derivative Liability, Measurement Input			0.0483	0.0483
Dividend yield
Private Placement
Embedded Derivative Liability, Measurement Input			0.080	0.080
Penalty dividend rate
Private Placement
Embedded Derivative Liability, Measurement Input			0.150	0.150
Probability of default
Private Placement
Embedded Derivative Liability, Measurement Input			0.040	0.040
Series A Preferred Stock
Private Placement
Number of equal monthly installments for redemption of preferred stock \| installment	13
Minimum trading days after the date that initial registration statement for considering first trading day of the calendar month	25 days
Percentage of redemptions payable in cash on installment redemption amount	107.00%
Percentage of the average of three lowest closing prices of common stock during the thirty trading day period immediately prior to amortization payment is due	80.00%
Number of trading days immediately prior to amortization payment is due considered for calculating conversion price	30 days
Conversion price for valuation of common stock \| $ / shares	$ 0.396
Percentage of minimum price	20.00%
Common stock closing price per share limit for conversion of stock for 20 consecutive trading days \| $ / shares	$ 6.75
Number of trading day considered for calculation of closing price limit of common stock for conversion	20 days
Daily dollar trading volume of common stock limit for conversion of stock	$ 2,000,000
Dividend rate	8.00%
Preferred stock, dividend accrued rate per annum	15.00%
Cash payable to investors			$ 1,144,582	$ 1,144,582
Stated value of the Series A Preferred Shares			965,006	965,006
Accrued dividends payable			$ 104,693	104,693
Cash premium				$ 74,883
Number of stock redeemed \| shares			3,000	8,983
Amount of stock redeemed for cash			$ 2,389,478	$ 5,089,417
Percentage of deferred premium installment				125.00%
Amount of penalty premiums			$ 598,336	$ 598,336
Number of common stock issued upon conversion \| shares			580,348	6,563,523
Value of common stock issued for conversion			$ 232,143	$ 6,586,033
Series A Preferred Stock \| Subsequent Events
Private Placement
Initial conversion price \| $ / shares							$ 2.25
Purchase Agreement \| Private Placement
Private Placement
Common stock, par value (in dollars per share) \| $ / shares	$ 0.0001
Purchase Agreement \| Series A Preferred Stock
Private Placement
Initial conversion price \| $ / shares	$ 2.25		$ 2.25	$ 2.25
Purchase Agreement \| Series A Preferred Stock \| Private Placement
Private Placement
Aggregate shares agreed to sell \| shares	15,000
Preferred stock, par value (in dollars per share) \| $ / shares	$ 0.0001
Preferred stock, stated value \| $ / shares	$ 1,000
Maximum shares issuable upon conversion \| shares	6,666,668
Warrants to purchase shares of common stock \| shares	6,666,668
Exercise price of warrants \| $ / shares	$ 2.25

Fair Value Measurements (Details)	Sep. 30, 2024 USD ($)
Level 3 \| Bifurcated embedded derivative liability
Fair Value Measurements
Total liabilities	$ 0

Fair Value Measurements - Change in the fair value of financial liabilities (Details) - Bifurcated embedded derivative liability	9 Months Ended
	Sep. 30, 2024 USD ($)
Change in the fair value of financial liabilities
Beginning Balance	$ 3,550,000
Change in fair value of bifurcated embedded derivative	(3,550,000)
Ending Balance	$ 0

Restatement of Previously Issued Financial Statements (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Accretion of Series A convertible preferred stock to redemption value		$ (1,153,846)		$ (1,153,846)
Net loss attributable to common stockholders	$ (5,246,715)	$ (6,042,586)	$ (16,008,578)	$ (9,974,416)
Basic (in dollars per share)	$ (0.53)	$ (2.85)	$ (2.18)	$ (4.73)
Diluted (in dollars per share)	$ (0.53)	$ (2.85)	$ (2.18)	$ (4.73)
Supplemental disclosure of cash flows information
Accretion of Series A Convertible Preferred Stock To Redemption Value			$ 9,099,230	$ 1,153,846
As reported
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Net loss attributable to common stockholders		$ (4,888,740)		$ (8,820,570)
Basic (in dollars per share)		$ (2.31)		$ (4.18)
Diluted (in dollars per share)		$ (2.31)		$ (4.18)
Supplemental disclosure of cash flows information
Accretion of Series A Convertible Preferred Stock To Redemption Value				$ 1,250,000
Adjustment
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Accretion of Series A convertible preferred stock to redemption value		$ (1,153,846)		(1,153,846)
Net loss attributable to common stockholders		$ (1,153,846)		$ (1,153,846)
Basic (in dollars per share)		$ (0.54)		$ (0.55)
Diluted (in dollars per share)		$ (0.54)		$ (0.55)
Supplemental disclosure of cash flows information
Accretion of Series A Convertible Preferred Stock To Redemption Value				$ (96,154)

Subsequent Events (Details) - USD ($)				1 Months Ended	9 Months Ended
Subsequent Events (Details) - USD ($)	Oct. 16, 2024	Oct. 15, 2024	Oct. 01, 2024	Oct. 31, 2024	Sep. 30, 2024	Nov. 13, 2024	Oct. 13, 2024	Oct. 11, 2024
Notes payable
Subsequent Events
Interest rate at the time of default (in percent)					9.00%
Subsequent Events
Subsequent Events
Additional interest expense accrued			$ 50,000
Redemption premium percentage of installments				$ 125
Total penalty premium				$ 207,201
Cash and cash equivalents						$ 1,500,000	$ 1,500,000
Subsequent Events \| Series A Preferred Stock
Subsequent Events
Initial conversion price								$ 2.25
Subsequent Events \| President and Chief Commercial Officer
Subsequent Events
Annual salary	$ 280,000	$ 350,000
Subsequent Events \| Notes payable
Subsequent Events
Additional interest expense accrued			50,000
Payment for notes and security agreement			$ 500,000
Interest rate at the time of default (in percent)			9.00%

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